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Recall Observatory FDA recall evidence

Device product

Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

Z-1413-2015

March 23, 2015

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 70839
Status
Terminated
Classification
Class II
Quantity
2620 units
Official record key
device-enforcement:Z-1413-2015

Official wording

Reason: Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

Code information: Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.