Device recall: Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Class I FDA enforcement event 92321. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
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 14 Jun 2023. The firm address in the FDA record is in Danvers, MA. FDA put the recall in Class I. FDA event 92321 has 6 product records. The first FDA enforcement report date is 26 Jul 2023. The record gives the status Ongoing.
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 . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide.
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
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2111-2023 | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | 9252 units | Class I | Ongoing | 26 Jul 2023 |
| Z-2112-2023 | Impella 5.0 intravascular micro axial blood pump, Product Number 005062 | 9252 units | Class I | Ongoing | 26 Jul 2023 |
| Z-2113-2023 | Impella LD intravascular micro axial blood pump, Product Number 005082 | 9252 units | Class I | Ongoing | 26 Jul 2023 |
| Z-2114-2023 | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100 | 9252 units | Class I | Ongoing | 26 Jul 2023 |
| Z-2115-2023 | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 | 9252 units | Class I | Ongoing | 26 Jul 2023 |
| Z-2116-2023 | Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 | 9252 units | Class I | Ongoing | 26 Jul 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
- 6Median of the firm: 1
- Events of the firm on the register
- 30
Other events of the firm
Official channels
- FDA enforcement report Z-2111-2023The 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.
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Cite this page
Recall Register. FDA enforcement event 92321. https://recallregister.com/fda/i/92321/. Source: openFDA enforcement reports. Data through .
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.
- What quantity of product is in FDA event 92321?
- The event has 6 product records. The first record gives this quantity:
9252 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.