Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in
Pending LLM rewrite. Source: FDA_DEVICE Z-1589-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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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