Medical Device News Update - March 2025

FDA approvals, warning letters and Class I recalls issued during March 2025

Monthly roundup of FDA approvals, warning letters and recalls issued in March 2025

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful in building awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Only publicly available information is curated in this article. Links to relevant sources are provided in the footnotes.

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Quick Summary

New device approvals/clearances

1. An automated endoscope channel cleaning device (DEN240018).

2. An in-vitro diagnostic test for detection of sexually transmitted diseases (DEN240020).

3. A total of 246 devices were cleared through the 510(k) pathway during March 2025. Days to FDA decision ranged from 3 to 574 days with a median of 115 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Neurology (NE) and Gastroenterology & Urology (GU), accounting for 63% (156/246) of devices cleared.

FDA warning letters

FDA issued two warning letters to medical device manufacturers in March 2025.

1. EpiCare Acquisitions, LLC: Quality system violations - design validation, complaints handling, adverse events reporting, CAPA, device history records, device master records, personnel training.

2. Dexcom, Inc.: Quality system violations - process validation, design input, design changes, design output, design validation, CAPA.

Class I recall announcements and early alerts

1. Getinge: risk of degradation inside a vaporizer used for general anesthesia (Removal).

2. Philips: risk of additional intervention due to challenges during implantation of the Tack Endovascular System (Removal and product discontinuation).

3. Baxter: risk of patient injury due to incorrect assembly of some solutions sets used in infusion pumps (Removal).

4. Fresenius Kabi USA: risk of under or over-dosing, or delay in therapy due to software issues in an infusion pump system (Correction).

5. Medtronic: risk of incomplete wall attachment and braid deformation in an embolization device used to treat brain aneurysms (Removal and Correction).

6. Smiths Medical: risk of port detachment used for venous access for repeated blood draws (Removal).

7. Bard Peripheral Vascular (BD): risk of vessel damage due to fracture of a rotating helix in an atherectomy device (Correction).

8. Baxter: risk of inadequate or delayed therapy due to missing motor mounting screws in infusion pumps (Removal).

9. Calyxo: risk of excessive kidney pressure in patients during aspiration (Early Alert).

10. BD: risk of incorrect or inadequate infusion from Alaris system due to system and software issues (Correction).

11. Smiths Medical: risk of inadequate ventilation due to smaller than expected diameter of endotracheal tubes (Removal).

12. Medtronic: risk of loose material in the male luer used in an aortic root cannula (Recall).

Let us take a closer look.

I. Innovation

Here is a summary of De-Novo decisions, PMA approvals and 510(k) clearances in the month of March 2025. See footnotes for links to additional information.

A. De-Novos

1. DEN240018: CORIS System, Automated endoscope channel cleaner¹
   This device is used to clean the channels of the Olympus EVIS EXERA III CF-HQ190L colonovideoscope. As an automated endoscope cleaning device, it is intended to replace all or portion of manual cleaning. This device is not intended to provide or replace high-level disinfection or sterilization.

   Product Code NTP, Class II, Regulation 21 CFR 876.1550

2. DEN240020: Visby Medical Women's Sexual Health Test²
   This in-vitro diagnostic test is used for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments

   Product Code SEA, Class II, Regulation 21 CFR 866.3386

B. Premarket Approvals (PMA) - Original only

FDA did not approve any original PMAs in March 2025.

C. Premarket Notifications (510k)

FDA cleared a total of 246 devices through the premarket notification process during March 2025. A majority of these devices (78%, 192/246) were cleared through the Traditional 510k process.

Following graphic provides an overview of these 510k’s.

Figure xx: Summary of 519k clearances in March 2025

Here are the key highlights:

• Top 5 medical specialties accounted for 63% of the total 510k (156/246) with median days to decision ranging from 88 to 177 days after receipt.

• Orthopedic (OR) medical specialty had the highest number of 510k (38/246) with 88 median days to decision after receipt. Top 5 product codes were in the Radiology, Orthopedic, General & Plastic Surgery, and Neurology medical specialties.

• QIH was the top product code corresponding to radiological image processing system in the Radiology category with 10 510k clearances.

• In aggregate, days to decision ranged from a minimum of 3 days to a maximum of 574 days after receipt, with a median of 115 days. 20th percentile of the devices were cleared within 61 days, while the 80th percentile were cleared within 244 days.

• A denture base resin was cleared in just 3 days after receipt (K250946, PRO Code: EBI).

• It took 574 days for the iPhysio(R) system, an Endosseous Dental Implant Abutment to receive 510k clearance as a Class II device (K232383, PRO Code: NHA).

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II. FDA Warning Letters

FDA issued two warning letters to medical device manufacturers during the month of March 2025.

1. CMS 702493 - EpiCare Acquisitions, LLC³

   1. Devices impacted: EpiCare-Zenith(TM) family of laser systems.

   2. Observations cited:

      1. Quality system violations - design validation, complaints handling, adverse events reporting, CAPA, device history records, device master records, personnel training.

2. CMS 700835 - Dexcom, Inc.⁴

   1. Devices impacted: G6 and G7 continuous glucose monitors.

   2. Observations cited:

      1. Quality system violations - process validation, design input, design changes, design output, design validation, CAPA.

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III. Medical Device Recalls/Early Alerts

In the month of March 2025, FDA published 12 Class I recalls and early alerts. This classification reflects the most serious type of recall, where the use of impacted devices may cause serious injuries or death.

1. Getinge: Vaporizer Sevoflurane Quick-Fil Recall⁵

   1. Device use: these vaporizers are part of the flow anesthesia system, used for containing, vaporizing and blending liquid sevoflurane with for general anesthesia.

   2. Reasons for recall: reports of discoloration and/or corrosion indicating risk of degradation to hydrogen fluoride.

   3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including irritation of respiratory tract leading to fluid buildup in the lungs (lung edema) and/or severely low levels of calcium in the blood (hypocalcemia), blistering, skin wounds (superficial ulceration), low levels of magnesium in the blood (hypomagnesemia), and death. There have been no reports of injuries or deaths due to this issue.

2. Philips: Tack Endovascular System Recall⁶

   1. Device use: The Tack Endovascular System (TES) is used to treat vascular dissection following widening of the blood vessel using a balloon or stent.

   2. Reasons for recall: challenges during use leading to additional interventions.

   3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including short-term risks of partial or completely blocked blood flow (occlusion), holes or tears in the inner lining of the artery (dissection) through the entire artery wall (perforation), as well as long term risks such as pain, tissue loss, re-narrowing of a widened or stented vessel (restenosis), the need for bypass surgery, amputation, and death. There have been 20 reports of injuries but no deaths related to this issue.

3. Baxter: Solution Set Recall⁷

   1. Device use: These solution sets are used to administer fluids from a container to patients through a vascular access device, such as an infusion pump.

   2. Reasons for early alert: incorrect assembly of some solution sets with duo-vent spikes.

   3. Patient safety impact: Critical adverse health consequences may occur if the patient does not receive life-sustaining medication or if a significant amount of blood is removed from the patient, especially for high-risk populations, such as neonates or critically ill patients. There have no reports of injuries or deaths.

4. Fresenius Kabi USA: Infusion Pump Software Correction⁸

   1. Device use: Ivenix LVP software is embedded in the Ivenix family of infusion sytems, used to deliver infusion therapy to an individual patient.

   2. Reasons for recall: risk of under-dosing, over-dosing or delay in therapy due to software issues in version 5.9.2 or earlier.

   3. Patient safety impact: Underdosage may lead to patient harm including temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes. Over infusion may lead to patient harm including hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation. There have been no reports of injuries or deaths due to this issue.

5. Medtronic: Pipeline Vantage Embolization Device Recall and Correction⁹

   1. Device use: Pipeline Vantage Embolization Devices with Shield Technology are used to treat bulges in the artery walls (aneurysms) of the brain.

   2. Reasons for recall: increase in risk of incomplete wall attachment and braid deformation, especially in females younger than 45 years old.

   3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including thrombosis, stroke, or death. There have been 13 reports injuries and 4 deaths due to this issue.

6. Smiths Medical: ProPort Plastic Implantable Ports Recall¹⁰

   1. Device use: ProPort Plastic Implantable Ports are part of a system for accessing veins, used when patient therapy requires repeated venous access for injections, infusions, and/or blood samples.

   2. Reasons for recall: manufacturing defect that may cause the plastic port housing and port reservoir to separate before, during, or after implantation.

   3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including complications from the delay or interruption of life-saving therapies, damage or scarring to skin or tissue surrounding the port from contact with leaking intravenous medications such as chemotherapy, air entering the bloodstream (air embolism), and death. There have been 2 reports of injuries but no deaths due to this issue.

7. Bard Peripheral Vascular (BD): Atherectomy Catheter System Correction¹¹

   1. Device use: the atherectomy system is used to break up and remove thrombus from peripheral arteries.

   2. Reasons for recall: risk of vessel injury due to fracture of the rotating helix portion.

   3. Patient safety impact: Use of the device in certain anatomy and lesion types, as well as certain procedural factors, may cause the helix to fracture or break, requiring retrieval of a broken catheter and/or device fragment. A helix fracture or break could cause vessel injury and may lead to severe bleeding or death. There have been reports of 30 injuries and 4 deaths related to this issue.

8. Baxter: Infusion Pump Recall¹²

   1. Device use: These Baxter Spectrum infusion pumps are intended to be used for the controlled administration of fluids.

   2. Reasons for recall: risk of insufficient or excessive therapy due to missing motor mounting screws.

   3. Patient safety impact: Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health consequences. There have been 1 report of serious injury but no deaths related to this issue.

9. Calyxo: Aspiration System Issue Early Alert¹³

   1. Device use: The CVAC System (CVAC Aspiration System and CVAC Image Processor) is used to establish a channel during endoscopic urological procedures for the treatment and removal of urinary stones.

   2. Reasons for recall: a new risk of injury during use of the CVAC aspiration system for patients with high viscosity fluid in the kidney at the start of the procedure.

   3. Patient safety impact: use of the device in this situation can cause reduced fluid outflow that can lead to excessive pressure in the kidney. If the increased pressure in the kidney is not addressed, serious injury or death may occur. There has been 1 deaths related to this issue.

10. Becton, Dickinson and Company (BD): BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Correction¹⁴

    1. Device use: a speed control dial in this device is used to control power to a mechanical wheelchair.

    2. Reasons for recall: risk of incorrect or inadequate infusion due to delayed system response and software issues.

    3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including complications caused by sudden pump stop or by receiving too much or too little therapy (over- or under-infusion) and death. There have been no reports of injuries or deaths related to this issue.

11. Smiths Medical: Intubation ORAL/NASAL Endotracheal Tubes Recall¹⁵

    1. Device use: ORAL/NASAL Endotracheal Tubes help keep air flowing through a patient’s airway.

    2. Reasons for recall: risk of inadequate ventilation due to smaller than expected diameter.

    3. Patient safety impact: The use of affected product may cause serious adverse health consequences, including lack of oxygen (hypoxia) that may to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death. There have been 8 injuries reported but no deaths related to this issue.

12. Medtronic: Aortic Root Cannula Recall¹⁶

    1. Device use: Aortic Root Cannulas are used for six hours or less during surgery with the heart-and-lung machine (cardiopulmonary bypass) .

    2. Reasons for recall: risk for unexpected loose material in the male luer used in the cannula.

    3. Patient safety impact: The loose material has the potential to become dislodged and cause serious patient adverse health consequences, including injuries caused by delayed therapy, stroke, and death. There have been no reported injuries and no reports of death.

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1. FDA: DENDEN240018 De Novo database entry.

2. FDA: DEN240020 De Novo database entry.

3. FDA: EpiCare Acquisitions warning letter.

4. FDA: Dexcom warning letter.

5. FDA: Getinge recall announcement.

6. FDA: Philips recall announcement.

7. FDA: Baxter recall announcement.

8. FDA: Fresenius Kabi USA recall announcement.

9. FDA: Medtronic recall announcement.

10. FDA: Smiths Medical recall announcement.

11. FDA: Bard Peripheral Vascular recall announcement.

12. FDA: Baxter infusion pump recall announcement.

13. FDA: Calyxo early alert announcement.

14. FDA: Beckton Dickinson recall announcement.

15. FDA: Smiths Medical endotracheal tube recall announcement.

16. FDA: Medtronic aortic root cannula recall announcement.