Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) co
See all recalls from Abiomed, Inc. →Recalled Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
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: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
✅ 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.
Looking for a safe alternative?
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