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

Recall number

Z-2601-2026

Recalling firm

Abiomed, Inc.

Product

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

Status

Open, Classified

Initiated

2026-05-22

Posted

2026-06-25

Terminated

not on file

Reason

Potential for thrombus formation during prolonged use of the introducer.

Root cause

Under Investigation by firm

Action

Abiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.

Quantity

168 units

Distribution

Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

Lot, serial or model codes

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, 653479, 653489, 653488, 653487, 653486, 653476, 653477, 656002, 656001, 656000, 655998, 655997, 655993, 655996, 655995, 655994, 656737, 656736, 656735, 656734, 656733, 656730, 656731, 656729, 656728, 656346, 656343, 656342, 656341, 656340, 656338, 659804, 659795, 656347, 650264, 659801, 659802, 659800, 659799, 659798, 656363, 656367, 656362, 656361, 656360, 656359, 656358, 659794, 659793, 659791, 659792, 659790, 659789, 659788, 659786, 659787, 659785, 661408, 661407, 661405, 661404, 661392, 661391, 661389, 661403, 661402, 661401, 661400, 662657, 662654. Introducer Product Code: 2000785; Batch Numbers: 2026787668, 2027818660. Distributed in Japan.

510(k) numbers

["K241708"]

PMA numbers

not on file

Product code

DYB

Firm FEI

1220648

Firm city

Danvers

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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