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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Spectranetics Bridge Balloon Prep Kit

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 Class 2 Device Recall Philips Spectranetics Bridge Balloon Prep Kitsee related information
Date Initiated by FirmApril 02, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2002-2026
Recall Event ID 98637
Product Classification Angiography/angioplasty kit - Product Code OEQ
ProductPhilips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Code Information All Lot Numbers/UDI: 00884450771310
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information ContactMerit Customer Service
1800-356-3748
Manufacturer Reason
for Recall		catheter may experience resistance when being advanced over the guidewire
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
DistributionUS Nationwide distribution in the state of CO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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