FDA Adverse Event
Malfunction
Summary report: N
IMPELLA OPTICAL CONTROLLER, PACKAGED, EU
MDR report key: 24115110
·
Received January 20, 2026
Report
- Report Number
- 1220648-2026-01119
- Event Type
- Malfunction
- Date Received
- January 20, 2026
- Date of Event
- January 12, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502010961
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6, MEDICAL DEVICE PROBLEM CODE A150105 HAS BEEN REMOVED AND UPDATED WITH A1101.
Additional Manufacturer Narrative · 0
A4, A5, AND A6 ARE UNKNOWN. 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN AUTOMATED IMPELLA CONTROLLER DID NOT WORK. THE FLIGHTMODE BUTTON WAS BLINKING CONTINUOUSLY AND FLIGHMODE WAS NOT CONNECTED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116212 | IMPELLA OPTICAL CONTROLLER, PACKAGED, EU | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 1452267 | 00813502010961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |