Lower risk Medical device recall · FDA · Published May 22, 2026

Abiomed Impella CP Set with SmartAssist: Risk of Blood Clots During Prolonged Use

Abiomed recalls 10th Gen Impella CP Set with SmartAssist containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Product codes and serial numbers listed for identification.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2601-2026Medical device Abiomed ›

Lower-risk recall

Potential for thrombus formation during prolonged use of the introducer.

Take action

Contact the company

Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling its 10th Generation Impella CP Set with SmartAssist that includes certain 14Fr Low Profile Introducer Kits. The recall is because these kits may cause blood clots if used for extended periods. Read more at govinfonow.com/recall/49074-abiomed-impella-cp-set-with-smartassist-risk-of-blood-clots.

Source Summary by GovInfoNow · govinfonow.com/recall/49074-abiomed-impella-cp-set-with-smartassist-risk-of-blood-clots · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2601-2026

Cite this page

“Abiomed Impella CP Set with SmartAssist: Risk of Blood Clots During Prolonged Use.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49074-abiomed-impella-cp-set-with-smartassist-risk-of-blood-clots. Based on FDA recall #Z-2601-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2601-2026%22&limit=1).

The FDA announced on May 22, 2026, that Abiomed, Inc. is voluntarily recalling the Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits due to a potential for thrombus formation during prolonged use.

How to tell if you have it

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits
Product Code: 1000413; GTIN: 00813502013566; Serial numbers: 649727-653041, 654333-654387, 655733-655742, 656735-656743, 653042-653050
Introducer Product Code: 2000684; Batch Numbers: 2026724558, 2027818724
Product Code: 1000834; GTIN: 00813502013948; Serial numbers: 653462-653490, 655993-656002, 656338-656367, 656728-656737, 659785-659804, 661389-661408, 662654, 662657
Introducer Product Code: 2000785; Batch Numbers: 2026787668, 2027818660

The hazard

The recall addresses the potential for thrombus formation during prolonged use of the introducer. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls include an Abiomed Impella Optical Controller Recall on 2026-08-12 regarding purge cassette recognition issues and an Abiomed Intro Kit Recall on 2026-06-11 involving potential sheath leakage risk. Similar recent recalls of comparable medical devices include an AVID Medical Halyard Kits Recall on 2026-04-30 for particulates risk blood clots and a B Braun Blood Administration Set Recall on 2025-10-29 for the risk of medication backflow.

How to tell if you have this one

Check for product codes 1000413 or 1000834, and serial numbers listed in the recall notice. The kits were distributed in Japan and include specific batch numbers for identification.

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

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

Recall number	Product, codes & lots	Quantity
Z-2599-2026	Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.; Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.	3 units
Z-2600-2026	Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.; Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.	17 units
Z-2601-2026	Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.; 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.	168 units
Z-2602-2026	Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.; Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.	7 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your Impella CP Set with SmartAssist (10th Generation) has the product codes 1000413 or 1000834 and the listed serial numbers or batch numbers.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Illinois, Minnesota, New Jersey, New York, Virginia.

Recall timeline

FDA published this recall 40 days after the firm started it.

May 22, 2026Firm started the recall
Jun 25, 2026FDA classified it Class I
Jul 1, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49074-abiomed-impella-cp-set-with-smartassist-risk-of-blood-clots">Abiomed Impella CP Set with SmartAssist: Risk of Blood Clots During Prolonged Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2601-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2601-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.