FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Recall number
- Z-2004-2026
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Status
- Open, Classified
- Initiated
- 2026-04-02
- Posted
- 2026-04-29
- Terminated
- not on file
- Reason
- catheter may experience resistance when being advanced over the guidewire
- Root cause
- Nonconforming Material/Component
- Action
- On April 17, 2026, Merit Medical Issued a Urgent Medical Device Recall notification via: FedEx. Initial notification was issued on April 2, 2026 via E-Mail and FedEx. Merit ask consignees to take the following actions: 1. Ensure that applicable personnel within your organization are made aware of this safety notice. 2. If the product has been further distributed to other facilities, institutions, or manufacturers, please immediately share this safety notice in accordance with your company policies. Please consider communicating the following to your customers: a. For continued safe use of the Philips Bridge" and Philips Bridge" Plus Occlusion Balloons, as outlined in the Prophylactic Directions for Use in the IFU, the following actions should be taken prior to the beginning of any procedure to confirm proper interaction between devices: i. After placement of the guidewire, advance the Balloon over the guidewire. This will confirm that the Balloon can freely be advanced over the entire length of the guidewire without resistance, thereby confirming that the guidewire is compatible with the Balloon. ii. Should resistance be felt during this step, the guidewire should be replaced with an alternate 0.035 stiff/super stiff wire, and Step 1 should be repeated prior to the beginning of the procedure. 3. Please circulate this information to all users of the Philips Bridge", Philips Bridge" Plus, and Bridge" Prep Kit device, or to any organization where the affected product may have been transferred, so that they are aware of the issue. Merit encourages you to instruct your customers to post the safety notice on or near the affected products.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the state of CO.
- Lot, serial or model codes
- All Lot Numbers/UDI: 00884450024140
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEQ
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28