Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella
See all recalls from Abiomed, Inc. →Recalled Product
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Hazard / Issue
Potential for thrombus formation during prolonged use of the introducer.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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