CLASS II ONGOING Device recall · Reported 11 Sep 2024 · FDA Enforcement Report

ImpellaCP SmartAssistSetAPAC, Delo1895 recalled by Abiomed

Abiomed is recalling ImpellaCP SmartAssistSetAPAC, Delo1895, distributed nationwide in the US. The recall was initiated on 5 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;

Quantity recalled8 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-2967-2024
FDA event ID: 95129
Recalling firm: Abiomed, Danvers, MA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Aug 2024
FDA classified: 4 Sep 2024
Reported: 11 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Aug 2024	Recall initiated by company
4 Sep 2024	Classified by FDA	+30 days
11 Sep 2024	Published in enforcement report	+7 days

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

Reason for recall

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

Product as listed by the FDA

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

12 other products · FDA event 95129

Reported	Class	Recall	Company	Reason	Where
11 Sep 2024	CLASS II	Impella CP Pump 371 Set, Clinical Trial recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 SmartAssist Set, JP recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 with SmartAssist Set, EU recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella CP Smart Assist Set APAC recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella CP Smart Assist Set recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 SmartAssist S2 Set, JP recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella CP Smart Assist Set, Canada recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 with SmartAssist S2 Set, EU recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 with SmartAssist Set, CA recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella CP Pump Set, Japan recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 Set AU recalled by Abiomed	Abiomed	Other	Nationwide
11 Sep 2024	CLASS II	Impella 5.5 with SmartAssist Set, US recalled by Abiomed	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