Medical Device News Update - April 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in April 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 to study to build 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 AI/ML enabled software device to identify patients at risk for developing or having sepsis (De Novo DEN230036).

2. A spinal fusion device with antibacterial coating (De Novo DEN220015).

3. A limb and joint salvage device with antibacterial coating (De Novo DEN210058).

4. A surgical system for open microsurgery (De Novo DEN230032).

5. A continuous glucose monitoring device (De Novo DEN230052).

6. A radiology software to aid in detecting low bone mineral density (De Novo DEN230023).

7. A breakthrough device to repair the native tricuspid value without open heart surgery (PMA, Original, P230007).

8. A breakthrough device to visualize residual cancerous tissue following lumpectomy (PMA, Original, P230014).

9. A breakthrough drug-coated resorbable stent to open up the infrapopliteal artery diameter and prevent lower limb amputations (PMA, Original, P230036)

10. A total of 252 devices were cleared through the 510(k) process during April 2024. Days to FDA decision ranged from 1 to 1318 days with a median of 172 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 65% (164/252) of devices cleared.

FDA warning letters

1. Cardinal Health: Marketing of unauthorized syringes in a kit. Additional quality system violation related to purchasing controls.

2. Pinnacle BioLabs: Marketing of a medical device without FDA approval or clearance. Additional quality system violations in design controls, complaints handling, CAPA and MDR reporting.

3. Bioptimal International: Marketing of medical devices without FDA approval or clearance. Additional quality system violations in design controls, complaints handling, process validation, CAPA and MDR reporting.

Class I recall announcements

1. Teleflex/Arrow International: radial artery and catheterization kits for increased resistance that may cause blood vessel injury, narrowing or blockage.

2. Smiths Medical ASD Inc.: ventilator kit malfunction may cause non-cycling, continuous positive gas flow and improper ventilation.

3. Medos International: cracking of a neurovascular catheter may cause delay in procedure, vascular injury, hemorrhage or embolism in the brain.

4. Abbott/Thoratec Corp.: left ventricular assist system due to long-term build up of biological material may cause obstruction and loss of blood flow.

5. Boston Scientific: embolic agent delivery device for increased risk of bowel ischemia when used to stop lower GI bleeding.

6. Fresenius Kabi USA: infusion pump software issues that may lead to serious injury or death.

7. DeRoyal Industries: convenience kits containing urine meter foley impacted by Nurse Assist recall due to sterility issues.

8. Fresenius Medical Care: catheter extension sets and accessories for risk of exposure to higher than allowable levels of toxic compound NDL-PCBAs.

9. Outset Medical: hemodialysis system for risk of exposure to higher than allowable levels of toxic compound NDL-PCBAs.

10. Draeger Inc.: sudden unexpected shutdown of anesthesia system in battery mode may cause delay/interruption in treatment.

11. InfuTronix LLC: multiple device failure modes of an infusion system may lead to serious injury and death.

12. Elekta Instrument AB: microscopic steel debris inside a disposable biopsy needle used to extract brain tumor sample.

13. SonarMed Inc.: software issue in an airway monitor system resulting in failure to detect partial obstruction in sensor tips.

14. SonarMed Inc.: restriction in acoustic sensors used in an airway monitoring system causing difficulty in using suction catheter during use.

15. BioMerieux Inc.: higher than normal levels of antibiotics in testing well of a diagnostic card used to detect antibiotic resistance to bacteria.

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