[pending] Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Pending LLM rewrite. Source: FDA_DEVICE Z-2457-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Devices
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
Distributed in 7 states:
- GA
- IA
- NE
- PA
- TX
- WA
- WI
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