Impella CP sets may lose mechanical circulatory support from low purge pressure
Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Impella CP Set with SmartAssist, product codes 1000080, 1000851, 0048-0014 and 0048-0024-JP, GTIN 00813502012279, from Abiomed, Inc., is being recalled. The action covers 10 units, identified by the serial numbers in the recall notice.
The stated reason is that 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. The FDA classified the action as Class I, its most serious classification.
Distribution was within the United States, to Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington and Wisconsin, and internationally including to Czechia. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product codes, GTIN and serial numbers in the recall notice, quarantine it, and follow the instructions issued by Abiomed.
The recalled product
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Manufacturer
- Abiomed, Inc.
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223
- 672986
- 673252
- 644591
- 645428
- 644314
- 613525)
- 1000851 (636173)
- 0048-0014 (499250)
- 0048-0024-JP (661216).
Distribution
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