Medical Device News Update - May 2025

FDA device approvals, warning letters, adverse events and recalls issued during May 2025

Monthly roundup of FDA approvals, warning letters, adverse events and recalls in May 2025

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, adverse events and recalls 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 how 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 mammography-based AI risk prediction platform to predict future breast cancer risk (DEN240047).

2. A peripheral retrievable stent system for controlled penetration and lesion treatment in below-the-knee procedures (DEN240048).

3. An ELISA test for dose adjustment of treatment for hemophilia patients (DEN240035).

4. A vaginal sample collection device for home use and transport for HPV testing (DEN240045).

5. A Transcatheter Mitral Valve Replacement (TMVR) System for the treatment of symptomatic severe mitral valve dysfunction (P240042).

6. An Endovascular Venous Anastomosis Connector for better management of end-stage dialysis patients (P240004).

7. A CDx to identify patients with non-squamous, non-small cell lung cancer (NSQ-NSCLC) eligible for MET-targeted treatment (P240037).

8. A total of 302 devices were cleared through the 510(k) pathway during May 2025. Days to FDA decision ranged from 1 to 587 days with a median of 137 days. Top 5 medical specialties were Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), Orthopedic (OR), and Dental (DE) , accounting for 60% (181/302) of devices cleared.

FDA warning letters

FDA issued five warning letters to medical device manufacturers in May 2025.

1. NeuroSync, Inc.: design controls, risk analysis, CAPA, purchasing controls, acceptance activities, MDR reporting, labeling.

2. Kabe Labortechnik GmbH: process validation, production and process controls, design controls, CAPA, non-conforming product, MDR reporting.

3. Microspecialties, LLC: finished device acceptance, process validation, statistical techniques.

4. DFI Co., Ltd.: complaints handling, non-conforming product, device labeling, DHR, acceptance status, MDR reporting.

5. Sedecal S.A.: CAPA, design validation, corrections and removals, required records for radiation safety.

Medical device adverse events (FDA)

A total of 169,850 device adverse events were reported to the FDA in May 2025, including 875 deaths. Device malfunctions accounted for 75% and injuries accounted for 24% of these reported events. Class II and Class III devices respectively accounted for 67% and 27% of these adverse events.

Consistent with last month, top 3 device codes associated with deaths were OZD (left heart support pump), DSQ (ventricular assist), and NPT (aortic valve), collectively accounting for 35% of reported deaths.

Data source provided by Orca1.ai.

Medical device recalls

There were 15 Class I recalls, 58 Class II recalls, and 1 Class III recall in May 2025. Top 5 recalling firms included Philips Medical (4), Medline (4), ICU Medical (4), Onkos Surgical (3) and Baxter Healthcare (3). Process control, device design, software design, and non-conforming material/component were the top causes (36/74) as determined by the FDA.

Data source provided by Orca1.ai.

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