Bridge Prep Kit recallZ-2003-2026 · Merit Medical Systems, Inc. · initiated Apr 2, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

catheter may experience resistance when being advanced over the guidewire

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number: Z-2003-2026
Status: Open, Classified
Initiated by the company: Apr 2, 2026
Posted by the FDA: Apr 29, 2026
Recalling firm: Merit Medical Systems, Inc.
Product code: OEQ
Distribution: US Nationwide distribution in the state of CO.

Product description

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Code information (models, lots, serial numbers)

All Lot Numbers/UDI: 00884450816509

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Bridge™ Prep Kit 00884450816509
Merit Medical Systems, Inc. · Angiography/angioplasty kit
2 recalls0 reports

Product lines

Bridge Prep KitMerit Medical Systems, Inc. · 4 models · 6 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98637).

Z-2002-2026 · Open, Classified
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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