FDA Adverse Event
Malfunction
Summary report: N
PUMP 371 14F LT CMR SET
MDR report key: 24225163
·
Received January 30, 2026
Report
- Report Number
- 1220648-2026-01985
- Event Type
- Malfunction
- Date Received
- January 30, 2026
- Date of Event
- November 12, 2025
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 813502011876
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6: PER A REVIEW OF THE COMPLAINT FILE. OMITTED CODE F26 AND A0207. ADDED A020602.
Additional Manufacturer Narrative · 0
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.
Additional Manufacturer Narrative · 0
PRIMARY UDI NUMBER WAS CORRECTED.
Description of Event or Problem · 0
A 48 YEAR OLD FEMALE WAS TREATED FOR CARDIOGENIC SHOCK. WHEN OPENING THE IMPELLA CP PACKAGING, THE RED FLAGGED GUIDEWIRE ASSIST WASN'T IN PLACE AND THE DECISION WAS MADE TO OPEN A REPLACEMENT PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596892 | PUMP 371 14F LT CMR SET | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | PUMP 371 14F LT CMR SET | 2026736431 | 813502011876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |