Official recall record
Impella LD intravascular micro axial blood pump, Product Number 005082
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-14
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00813502011227
- Brand on record
- Abiomed, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-09-18 · US FDA — Medical Devices
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-base - 2026-09-18 · US FDA — Medical Devices
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-base - 2026-09-18 · US FDA — Medical Devices
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-bas
All 38 official recall notices naming Abiomed, Inc. on this site →
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