FDA-Device2015-04-22Class II

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

Bard Peripheral Vascular Inc
Hazard

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

Sold states
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.
Affected count
2620 units
Manufactured in
1625 W 3rd St Ste 109, N/A, Tempe, AZ, United States
Products
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1413-2015

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