Medical Device News Update - December 2024

FDA approvals, warning letters and Class I recalls issued during December 2024

Monthly roundup of FDA approvals, warning letters and recalls issued in December 2024

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. A qualitative assay to aid in diagnosis of mature B-cell lymphomas and plasma cell neoplasms (De Novo DEN240025).

2. Spinal cord stimulation device to improve hand sensation and strength in patients with spinal cord injury (De Novo DEN240014).

3. A breakthrough device to remove accumulated fluid in patients with liver cirrhosis (PMA, Original, P230044).

4. A breakthrough device for treatment of stenosis or occlusion in hemodialysis patients (PMA, Original, P240023).

5. A phrenic nerve stimulator to improve weaning success in patients on ventilators (PMA, Original P240012).

6. A total of 296 devices were cleared through the 510(k) pathway during December 2024. Days to FDA decision ranged from 1 to 809 days with a median of 115 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Dental (DE) and Cardiovascular (CV), accounting for 59% (174/296) of devices cleared.

FDA warning letters

1. Integra LifeSciences Corporation: Quality system violations - control of nonconforming products, acceptance activities, CAPA, process validation, production and process controls.

2. Hologic, Inc: Quality system violations - design control, CAPA, MDR reporting

3. Anne’s Daye Ltd.: Marketing of unapproved devices, complaint handling violations.

4. Phillips Precision, Inc.: Quality system violations - process validation, production and process control, CAPA, control of nonconforming product, acceptance activities, personnel training.

5. Xoran Technologies, LLC: Quality system violations - purchasing controls, design validation, risk analysis, complaints handling.

6. Randox Laboratories Limited: Quality system violations - design validation, risk analysis, CAPA.

Class I recall announcements and early alerts

1. Cardinal Health: insulin syringe incompatibility with needleless connectors.

2. GE Healthcare: risk of formaldehyde exposure in neonatal incubators.

3. Fresenius Kabi: risk of infusion pump valve failure.

4. Hologic: risk of complications and adverse events from implantable radiological markers.

5. Boston Scientific: risk of esophageal injury from cryoablation balloon catheters.

6. Trokamed GmbH: risk of misuse due to missing warnings and precautions in the IFU for nephroscope sheath.

7. ICU Medical: reports of counterfeit batteries being used in infusion systems.

8. Olympus: risk of exposure contaminated endoscope accessory.

9. Nuwellis: risk of termination of blood filtration therapy due to too many alarms.

10. Medline: incorrect assembly of fluid delivery set in a convenience kit.

11. Baxter: incorrect assembly of solution sets used in infusion pumps.

Let us take a closer look.