Device recall: Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

Class I FDA enforcement event 92411. Recall start date: 29 Jun 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Abiomed, Inc. started this device recall on 29 Jun 2023. The firm address in the FDA record is in Danvers, MA. FDA put the recall in Class I. FDA event 92411 has 1 product record. The first FDA enforcement report date is 9 Aug 2023. The record gives the status Ongoing.

FDA enforcement report The 1 product record

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.

US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.

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

1 product record in the event.

FDA event 92411: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2281-2023	Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323	166 units	Class I	Ongoing	9 Aug 2023

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 I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class I: 10%
Product records in this event: 1Median 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-2281-2023The 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 92411. https://recallregister.com/fda/i/92411/. 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: US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.
What quantity of product is in FDA event 92411?: The FDA record gives this quantity: 166 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 10% of the 917 device events that started in 2023 are in Class I.