Impella purge cassettes recalled as Class I over purge leak risk
Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Purge Cassettes, sold within Impella Pump Sets and individually packaged, are being recalled across several configurations including the Purge Cassette 5 Pack (product code 0043-0003) and the Impella RP US Pump Set (product code 004334). About 33,107 units were distributed worldwide.
There is an increased risk of purge leaks with Generation 1 purge cassettes. The FDA has classified this recall as Class I, its most serious category.
Affected product is listed by configuration and product code in the FDA enforcement record.
Facilities can identify affected cassettes by the product code above, and may contact the recalling firm for further information.
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…
- Manufacturer
- Abiomed, Inc.
- Affected units
- 33,107
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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