Z-2003-2026Class II

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

Name: Z-2003-2026 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Creator: Merit Medical Systems, Inc.
Published: 2026-04-02
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2026-04-02 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY on 2026-04-02. FDA classified it as Class II and gives the reason as "catheter may experience resistance when being advanced over the guidewire". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2003-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-04-29
Recalling firm: Merit Medical Systems, Inc.
Product: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: catheter may experience resistance when being advanced over the guidewire
Root cause tag: manufacturing process
FDA 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.
Distribution: US Nationwide distribution in the state of CO.
Product codes and lots: All Lot Numbers/UDI: 00884450816509

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2003-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2002-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-2003-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-2004-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)