Z-2601-2026Class I

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer...

Name: Z-2601-2026 Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer...
Creator: Abiomed, Inc.
Published: 2026-05-22
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-05-22 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834 on 2026-05-22. FDA classified it as Class I and gives the reason as "Potential for thrombus formation during prolonged use of the introducer". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2601-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-22
Posted: 2026-06-25
Recalling firm: Abiomed, Inc.
Product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Product code: DYB Introducer, Catheter
Reason for recall: Potential for thrombus formation during prolonged use of the introducer.
FDA 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 in commerce: 168 units
Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2599-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2600-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2601-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25
Z-2602-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-25

Product code DYB

K241708Class IIAbiomed 14Fr Low Profile Introducer KitAbiomed, Inc. / cleared 2024-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)