FDA Adverse Event
Death
Summary report: N
IMPELLA CP
MDR report key: 24027324
·
Received January 9, 2026
Report
- Report Number
- 1220648-2026-00481
- Event Type
- Death
- Date Received
- January 9, 2026
- Date of Event
- January 6, 2026
- Report Date
- January 9, 2026
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE CAUSE OF ASAE/HEMATOMA/VESSEL PERFORATION: WAS NOT ESTABLISHED DUE INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN. DEVICE HISTORY LOT: DEVICE LOT: 1971298. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
Additional Manufacturer Narrative · 0
THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT A PATIENT DEVELOPED A LEFT GROIN HEMATOMA FOLLOWING IMPELLA INSERTION. THE PATIENT SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399081 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026752188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Death| R |