IMPELLA 5.5 WITH SMARTASSIST S2 SET, US
Report
- Report Number
- 1220648-2026-02050
- Event Type
- Malfunction
- Date Received
- February 2, 2026
- Date of Event
- January 28, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 813502012828
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: PURGE PRESSURE HIGH: THE CAUSE OF THE PURGE ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG.
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.
D6B EXPLANT DATE PROVIDED.
H6 CODES F2303 AND A140508 WERE REPORTED INCORRECTLY AND WERE REMOVED.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 EXPERIENCED LOW PURGE FLOW/PURGE SYSTEM BLOCK. NO KINKS WERE OBSERVED. THE PURGE CASSETTE WAS REPLACED AND TISSUE PLASMINOGEN ACTIVATOR WAS ADDED TO THE PURGE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187942 | IMPELLA 5.5 WITH SMARTASSIST S2 SET, US | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026795458 | 813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female |