IMPELLA
Report
- Report Number
- 1220648-2026-01817
- Event Type
- Malfunction
- Date Received
- January 29, 2026
- Date of Event
- January 18, 2026
- Report Date
- March 7, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED INFORMATION: D4 CATALOG NUMBER CORRECTED. H6 MED DEV PROB CODE ADDED A140508.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
D1 (BRAND NAME) & D4 (SERIAL) HAS BEEN UPDATED. D3 (MANUFACTURER FAX) HAS BEEN ADDED. DEVICE INTERACTION OR DAMAGE BY ANOTHER DEVICE: THE CAUSE OF DEVICE INTERACTION OR DAMAGE BY ANOTHER DEVICE WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.
B5 UPDATED WITH ADDITIONAL INFORMATION.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED SUCTION ISSUES WHILE EXTRACORPOREAL MEMBRANE OXYGEN (ECMO) WAS IN USE. ECMO WAS ADJUSTED TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
IT WAS FURTHER REPORTED THAT THE ISSUE WAS RESOLVED ONCE THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FLOWS WERE SORTED OUT AND THE DEVICE WAS NOT AVAILABLE FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52008 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026732724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |