Z-1413-2015 Class II Terminated
FDA device recall Z-1413-2015 was initiated by Bard Peripheral Vascular Inc on Mar 23, 2015 and is designated Class II. Reason for recall: Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. The recall status is terminated (terminated Aug 28, 2015). Affected quantity: 2620 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2015
- Initiation Date
- Mar 23, 2015
- Termination Date
- Aug 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2620 units
Product Description
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Reason for Recall
Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.
Distribution Pattern
Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia.
Code Information
Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1413-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026