CLASS I ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Impella CP with SmartAssist, Product No.: 1000080 recalled by Abiomed
Abiomed is recalling Impella CP with SmartAssist, Product No.: 1000080 (, distributed in Florida, Massachusetts, Texas. The recall was initiated on 31 May 2024 and the FDA has classified it as Class I.
Check your package
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-2319-2024
- FDA event ID
- 94833
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 31 May 2024
- FDA classified
- 17 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Processing Deviation
- Device type
- Heart & Vascular Devices
Timeline
| 31 May 2024 | Recall initiated by company | |
| 17 Jul 2024 | Classified by FDA | +47 days |
| 24 Jul 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
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Where it was distributed
Domestic only: FL, MA, OH TX.
Questions about this recall
Why was it recalled?
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Which lots are affected?
Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.
Where was it sold?
Domestic only: FL, MA, OH TX.
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.
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