Merit Medical Systems, Inc.: Angiography/angioplasty Kit
Recall Summary Merit Medical Systems is recalling the Philips Bridge Prep Kit, a medical device used in angiography and angioplasty procedures, because the catheter may experience resistance when being advanced over a guidewire. The recall affects units distributed nationwide across all 50 states plus Washington, DC. This is a Class II recall, meaning the device could cause serious health problems but is not expected to cause death.
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Reason
- catheter may experience resistance when being advanced over the guidewire
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of CO.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/44d31fb4-b63d-4225-a26e-b0ccf6fbca03