Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
USAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Recalling Firm: Abiomed, Inc.
Reason for Recall / Hazard
Potential for thrombus formation during prolonged use of the introducer.
Product Description & Identification
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 99002 |
| Address 1 | 22 Cherry Hill Dr |
| Address 2 | N/A |
| Code info | Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530. |
| Postal code | 01923-2575 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 7 units |
| Reason for recall | Potential for thrombus formation during prolonged use of the introducer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
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Overview
- Recalling FirmAbiomed, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
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🚨 SAFETY ALERT: Abiomed, Inc. - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. Check if your household is affected: https://therecallfile.com/recalls/abiomed-impella-cp-set-with-smartassist-10th-generation-containing-aff/FDA-Z-2602-2026
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