FDA DevicesClass I
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004...
Published: June 24, 2026Recall ID: Z-2457-2026Category: devicesCountry: US
Reason for Recall / Hazard
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Product Description & Identification
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 98946 |
| Address 1 | 22 Cherry Hill Dr |
| Code info | GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216). |
| Postal code | 01923-2575 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 10 units |
| Reason for recall | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Initial firm notification | Letter |
| Center classification date | 20260618 |
Overview
- Recalling FirmAbiomed, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan