Class I Recall

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

Summary

The FDA issued a Class I for Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14 by Abiomed, Inc.. Reason: Potential for thrombus formation during prolonged use of the introducer..

Details

Source

Device Recall

External ID

Z-2601-2026

Action Date

2026-07-01

Status

Ongoing

Product Description

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

Lot/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, 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.

Quantity Affected: 168 units

Reason for Recall

Potential for thrombus formation during prolonged use of the introducer.

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-22

Company

Abiomed, Inc.

Danvers, MA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.

Abiomed, Inc. has 70 FDA actions in our database, including 65 recalls and 5 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Abiomed, Inc. have FDA actions?

Abiomed, Inc. has 70 FDA actions in our database, including 65 recalls and 5 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2601-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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