Bard ConQuest PTA Balloon Dilatation Catheter Recalled for Deflation Risk
Bard Peripheral Vascular is recalling specific lots of the ConQuest PTA Balloon Dilatation Catheter due to a risk of deflation-related issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (deflation risk) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size (Product Code: CQ-75124). The recall involves 2,620 units distributed worldwide, including the United States, Puerto Rico, and various countries in Europe, Asia, Africa, and the Americas.
The recall is being conducted because the devices may be at risk of having deflation-related issues. The affected lots are REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, and REYC2575.
Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers. If the recalled devices are found, they should be removed from use and returned to the manufacturer or their distributor in accordance with the recall instructions.
The recalled product
- Product
- Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 2,620
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot No. REYA0973
- REYA2566
- REYC0372
- REYC0950
- REYC1426
- REYC2200
- REYC2365
- REYC2825
- REYC2575
Distribution
Distributed in 1 state:
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