Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...

Published: July 1, 2026Recall ID: Z-2601-2026Category: devicesCountry: US

Reason for Recall / Hazard

Potential for thrombus formation during prolonged use of the introducer.

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

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

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.