CLASS I ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report

Impella 2.5 intravascular micro axial blood pump recalled by Abiomed

Abiomed is recalling Impella 2.5 intravascular micro axial blood pump, Product Number 005042, distributed nationwide in the US. The recall was initiated on 14 Jun 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI: 00813502011081;

Quantity recalled9252 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-2111-2023
FDA event ID: 92321
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Ongoing
Recall initiated: 14 Jun 2023
FDA classified: 14 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

14 Jun 2023	Recall initiated by company
14 Jul 2023	Classified by FDA	+30 days
26 Jul 2023	Published in enforcement report	+12 days

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

Reason for recall

There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

Product as listed by the FDA

Impella 2.5 intravascular micro axial blood pump, Product Number 005042

Where it was distributed

Worldwide distribution - US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00813502011081;

Where was it sold?

Worldwide distribution - US Nationwide.

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

5 other products · FDA event 92321

This product is part of a recall event; the main page for the event is Impella LD intravascular micro axial blood pump recalled by Abiomed.

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023	CLASS I	Impella LD intravascular micro axial blood pump recalled by Abiomed	Abiomed	Other	Nationwide
26 Jul 2023	CLASS I	Impella 5.0 intravascular micro axial blood pump recalled by Abiomed	Abiomed	Other	Nationwide
26 Jul 2023	CLASS I	Impella CP with SmartAssist intravascular micro axial blood recalled	Abiomed	Other	Nationwide
26 Jul 2023	CLASS I	Impella CP intravascular micro axial blood pump recalled by Abiomed	Abiomed	Other	Nationwide
26 Jul 2023	CLASS I	Impella 5.5 with SmartAssist intravascular micro axial recalled	Abiomed	Other	Nationwide

More recalls from Abiomed

All 70

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Intro Kitand, PKGD, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella 5.5 Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Set, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide