Medical Device News Update - April 2025

FDA device approvals, warning letters, adverse events and recalls issued during April2025

Monthly roundup of FDA approvals, warning letters and recalls issued in April 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.

---

Quick Summary

New device approvals/clearances

1. A remote monitoring device for patients with epilepsy (DEN240062).

2. A behavioral therapy software device as an adjunct to acute and/or preventive treatments for migraine. (DEN240064).

3. A wearable belt that detects and activates an airbag to prevent injury from a fall (DEN240021).

4. A bassinet pad to treat infants born with neonatal opioid withdrawal syndrome (NOWS) (DEN240031).

5. A leadless cardiac synchronization therapy device (P240028).

6. A highly reliable lead for cardiac defibrillators (P240036).

7. A 7-day continuous wear cardiac defibrillator (P230022).

8. A total of 285 devices were cleared through the 510(k) pathway during April 2025. Days to FDA decision ranged from 4 to 438 days with a median of 126 days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), General & Plastic Surgery (SU), Cardiovascular (CV) and Neurology (NE) , accounting for 55% (156/285) of devices cleared.

FDA warning letters

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

1. Noah Medical Corporation: Quality system violations - CAPA, complaints handling, design controls, non-conforming product.

2. ICU Medical: Significant changes introduced in currently approved/cleared devices without FDA pre-market authorization.

Medical device adverse events (FDA)

A total of 200,157 device adverse events were reported to the FDA in April 2025, including 1167 deaths. Device malfunctions accounted for 69.3% and injuries accounted for 30.1% of these reported events. Class II and Class III devices accounted for 70.2% and 24.7% respectively.

Top 3 device codes associated with deaths were DSQ (ventricular assist), NPT (aortic valve) and OZD (left heart support pump), collectively accounting for 44% of reported deaths.

Data source provided by Orca1.ai.

Medical device recalls

There were 11 Class I recalls and 67 Class II recalls in April 2025. Top 5 recalling firms included Abbott (7), Beckton Dickinson (6), Medline (5), Medtronic (5) and Beckman Coulter (4). Process control, device design, software design, process change control, and non-conforming material/component were the top causes (42/78) as determined by the FDA.

Data source provided by Orca1.ai.

Let us take a closer look.