[pending] Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in
Pending LLM rewrite. Source: FDA_DEVICE Z-1589-2026.
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
Increased risk of purge leaks with Generation 1 purge cassettes.
The recalled product
- Product
- Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
- 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 (20)
- 2024309083
- 2024309085
- 2024309088
- 2024309091
- 2024309095
- 2024309099
- 2024309104
- 2024309109
- 2024309112
- 2024309333
- 2024309335
- 2024309339
- 2024309343
- 2024309346
- 2024309347
- 2024309349
- 2024309350
- 2024309351
- 2024309355
- 2024310812
Distribution
Distribution scope not specified by the agency.
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