Medical Device News Update - February 2025

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

Monthly roundup of FDA approvals, warning letters and recalls issued in February 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. A hydrogel based spinal sealant system for as an adjunct to sutured dural repair (PMA, Original, P240027).

2. A dermal filler for facial wrinkles and folds (PMA, Original, P240022).

3. A total of 236 devices were cleared through the 510(k) pathway during February 2025. Days to FDA decision ranged from 1 to 438 days with a median of 132 days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE), accounting for 61% (144/236) of devices cleared.

FDA warning letters

There were no warning letters to medical device manufacturers in February 2025.

Class I recall announcements and early alerts

1. Medtronic: risk of cracks and leaks in external CSF drainage and monitoring systems (Correction).

2. Baxter Healthcare: risk of ventilator failure due to a nonconforming battery charger (Correction).

3. JIANGSU JUMAO: risk of excessive heating and fire from oxygen concentrators (Removal).

4. Medline Industries: risk of detachment of excess material from arterial catheters due to a manufacturing issue(Removal).

5. Sentec/Percussionaire: risk of component failure in a continuous breathing circuit (Removal).

6. Abiomed: risk of unintended interaction between impella pump and catheter guidewire or other devices (Correction).

7. Boston Scientific Corporation: risk of pacemaker explant due to a manufacturing issue that causes the device to enter Safety Mode (Recall).

8. Olympus: risk of radiopaque tip detachment from an endoscope guide sheath (Recall).

9. ROi CPS, LLC: spring issue related to an emergency resuscitator component in a convenience kit used for labor and delivery (Recall).

10. Max Mobility: malfunction of a speed control dial in a wheelchair power assist device (Recall).

11. Philips: risk of patient falling from operating room tables (Correction).

12. Biosense Webster: higher risk of stroke or transient ischemic attack due to potential misuse (Correction).

Let us take a closer look.