IMPELLA CP
Report
- Report Number
- 1220648-2026-00118
- Event Type
- Injury
- Date Received
- January 5, 2026
- Date of Event
- December 10, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 813502011609
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A2 AND A4 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.
CORRECTION: SECTION B1 WAS MARKED FOR PRODUCT PROBLEM AS IT WAS LEFT UNCHECKED IN THE INITIAL REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THROMBOSIS: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS UNABLE TO BE DETERMINED DUE INSUFFICIENT CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED. DEVICE HISTORY LOT: DEVICE LOT: 1923316. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED NO PUMP FLOW AFTER A REPAIR OF THE VENTRICULAR SEPTUM WAS PERFORMED. THE IMPELLA WAS REPLACED WITH AN INTRA AORTIC BALLOON PUMP. UPON EXPLANT OF THE PUMP A THROMBUS WAS FOUND ON THE IMPELLER. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16635 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026685874 | 813502011609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |