Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
USAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
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. Product Codes: 1000413, 1000834.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 99002 |
| Address 1 | 22 Cherry Hill Dr |
| Address 2 | N/A |
| Code info | 1. Impella Set Product Code: 1000413; GTIN: 00813502013566; Serial numbers: 649727, 649728, 649729, 649730, 649731, 654349, 654348, 654342, 654341, 654340, 654339, 654338, 654336, 654335, 654334, 654333, 653010, 653009, 653008, 653007, 653006, 653005, 653004, 653003, 653002, 653001, 655735, 655733, 654357, 654356, 654382, 654383, 654381, 654380, 654378, 654367, 654366, 654364, 654365, 654362, 654363, 654361, 654360, 654359, 654358, 654379, 655734, 654386, 654355, 654385, 654384, 654353, 654352, 654351, 654350, 654387, 657649, 657648, 657646, 657647, 657645, 657644, 655742, 655739, 655741, 655740, 655738, 655737, 655736, 656743, 656738, 653050, 653049, 653048, 653047, 653045, 653044, 653043, 653042, 653041. Introducer Product Code: 2000684; Batch Numbers: 2026724558, 2027818724. 2. Product Code: 1000834. GTIN: 00813502013948. Serial numbers: 653474, 653471, 653485, 653470, 653469, 653468, 653467, 653465, 653466, 653463, 653464, 653482, 653483, 653484, 653481, 653490, 653462, 653478, 6... [TRUNCATED] |
| Postal code | 01923-2575 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 168 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. Product Codes: 1000413, 1000834. Check if your household is affected: https://therecallfile.com/recalls/abiomed-impella-cp-set-with-smartassist-10th-generation-containing-aff/FDA-Z-2601-2026
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