Abiomed Impella CP recalled for low purge pressure alarm risk
Abiomed's Impella CP Set with SmartAssist may experience low purge pressure issues that trigger repeated alarms. In some cases, this malfunction can interrupt or stop the device's mechanical heart support function.
From the FDA notice · Read the official notice ↗ · All Abiomed recalls
What to do
- If you use this device, contact Abiomed or your healthcare provider immediately about your specific serial number.
- Do not ignore persistent low purge pressure alarms — report them to your medical team right away.
- Check the device serial number against the affected list (1000080, 1000851, 0048-0014, 0048-0024-JP).
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Sold in
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Made for
- Adults (0 months and older)
Details
- Units affected
- 10 units
- Illnesses reported
- None reported
- Manufactured in
- 22 Cherry Hill Dr, Danvers, MA, United States
- Classification
- Class I
- Recall number
- Z-2457-2026
In the FDA's words
- Description
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. 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. GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216). Distribution: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan Affected quantity: 10 units
- 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.
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