Abiomed, Inc.: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product C
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Abiomed, Inc.
- Product
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- Reason / hazard
- Potential for thrombus formation during prolonged use of the introducer.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Recall initiated
- 2026-05-22
- Code info
- Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
- Product quantity
- 7 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Danvers
- State
- MA
- Country
- United States
- Event id
- 99002
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