CLASS I ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

Impella RP Flex with SmartAssist recalled by Abiomed

Abiomed is recalling Impella RP Flex with SmartAssist, distributed nationwide in the US. The recall was initiated on 27 Jan 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code: 1000323. UDI-DI: 00813502012811.

Quantity recalled4,496 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-1470-2026
FDA event ID: 98276
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Ongoing
Recall initiated: 27 Jan 2026
FDA classified: 27 Feb 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

27 Jan 2026	Recall initiated by company
27 Feb 2026	Classified by FDA	+31 days
11 Mar 2026	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

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Impella RP Flex with SmartAssist. Product Code: 1000323.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Nationwide

Questions about this recall

Why was it recalled?

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Which lots are affected?

Product Code: 1000323. UDI-DI: 00813502012811.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

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

2 other products · FDA event 98276

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026	CLASS I	Impella RP with SmartAssist recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
11 Mar 2026	CLASS I	Impella RP recalled by Abiomed	Abiomed	Device Malfunction	Nationwide

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