Device recall: Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

Class II FDA enforcement event 95129. Recall start date: 5 Aug 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Abiomed, Inc. started this device recall on 5 Aug 2024. The firm address in the FDA record is in Danvers, MA. FDA put the recall in Class II. FDA event 95129 has 18 product records. The first FDA enforcement report date is 11 Sep 2024. The record gives the status Ongoing.

FDA enforcement report The 18 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong,…

Recalling firm

Abiomed, Inc., Danvers, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

18 product records in the event.

FDA event 95129: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2954-2024	Impella CP Smart Assist Set, EU; Product Code: 0048-0014;	17,837 units	Class II	Ongoing	11 Sep 2024
Z-2955-2024	Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;	6,267 units	Class II	Ongoing	11 Sep 2024
Z-2956-2024	Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;	4 units	Class II	Ongoing	11 Sep 2024
Z-2957-2024	Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;	9 units	Class II	Ongoing	11 Sep 2024
Z-2958-2024	Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;	323 units	Class II	Ongoing	11 Sep 2024
Z-2959-2024	Pump 371 14F LT CMR Set; Product Code: 0048-0045;	43,636 units	Class II	Ongoing	11 Sep 2024
Z-2960-2024	Impella CP Smart Assist Set APAC; Product Code: 0048-0047;	705 units	Class II	Ongoing	11 Sep 2024
Z-2961-2024	Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;	1,889 units	Class II	Ongoing	11 Sep 2024
Z-2962-2024	Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;	21 units	Class II	Ongoing	11 Sep 2024
Z-2963-2024	Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;	2,916 units	Class II	Ongoing	11 Sep 2024
Z-2964-2024	Pump 381 Pump Set (US); Product Code: 1000080;	11,236 units	Class II	Ongoing	11 Sep 2024
Z-2965-2024	Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;	11,576 units	Class II	Ongoing	11 Sep 2024
Z-2966-2024	Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;	788 units	Class II	Ongoing	11 Sep 2024
Z-2967-2024	ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;	8 units	Class II	Ongoing	11 Sep 2024
Z-2968-2024	Impella 5.5 Set AU; Product Code: 1000361;	20 units	Class II	Ongoing	11 Sep 2024
Z-2969-2024	Impella CP Smart Assist Set; Product Code: 1000402;	39 units	Class II	Ongoing	11 Sep 2024
Z-2970-2024	Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;	286 units	Class II	Ongoing	11 Sep 2024
Z-2971-2024	Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;	413 units	Class II	Ongoing	11 Sep 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 18Median of the firm: 1
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Abiomed, Inc.
Initiated	Product (first record)	Type	Class	Records
12 Aug 2026	Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Contr	Device	Class I	3
11 Jun 2026	ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23	Device	Class I	13
22 May 2026	Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product C	Device	Class I	4
18 May 2026	Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.	Device	Class I	1
14 May 2026	Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with correspond	Device	Class I	1
20 Apr 2026	Automated Impella Controller (AIC); Product Code: 0042-0000-US;	Device	Class I	1
18 Feb 2026	Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat	Device	Class I	1
16 Feb 2026	Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Pa	Device	Class I	1
27 Jan 2026	Impella RP with SmartAssist. Product Code: 0046-0035.	Device	Class I	3
4 Dec 2025	Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.	Device	Class II	1

Abiomed, Inc.: all 30 events

Official channels

FDA enforcement report Z-2954-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 95129. https://recallregister.com/fda/ii/95129/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong,…
What quantity of product is in FDA event 95129?: The event has 18 product records. The first record gives this quantity: 17,837 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.