CLASS I ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report

Impella CP Set with SmartAssist (10th Generation) recalled by Abiomed

Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing Low Profile Introducer Kits, distributed nationwide in the US. The recall was initiated on 22 May 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesImpella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2602-2026
FDA event ID: 99002
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Ongoing
Recall initiated: 22 May 2026
FDA classified: 25 Jun 2026
Reported: 1 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 May 2026	Recall initiated by company
25 Jun 2026	Classified by FDA	+34 days
1 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for thrombus formation during prolonged use of the introducer.

Product as listed by the FDA

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Where it was distributed

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

Nationwide Florida Illinois Minnesota New Jersey New York Virginia

Questions about this recall

Why was it recalled?

Potential for thrombus formation during prolonged use of the introducer.

Which lots are affected?

Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99002

This product is part of a recall event; the main page for the event is Impella CP Set with SmartAssist (10th Generation) recalled by Abiomed.

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026	CLASS I	Impella CP Set with SmartAssist (10th Generation) recalled by Abiomed	Abiomed	Other	Nationwide
1 Jul 2026	CLASS I	Low Profile Introducer Kit for Impella CP. Impella Set recalled	Abiomed	Other	Nationwide
1 Jul 2026	CLASS I	Low Profile Introducer Kit for Impella CP. Impella Set recalled	Abiomed	Other	Nationwide

More recalls from Abiomed

All 74

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller with the below product recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide

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14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide