Merit Medical Systems, Inc.: Angiography/angioplasty Kit
Merit Medical Systems is recalling the Philips Bridge Prep Kit, a sterile medical device used in angiography and angioplasty procedures, because the catheter may experience resistance when being advanced over the guidewire. The recall affects units distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, indicating a potential health hazard.
- 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/a5c09c0a-be00-4d36-8c7c-3a2e2eef87d8