Abiomed Impella RP with SmartAssist recalled as Class I
Abiomed is recalling the Impella RP with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
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
Abiomed, Inc. is recalling the Impella RP with SmartAssist, product code 0046-0035. About 291 units were distributed worldwide, covering the United States nationwide and Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia and Switzerland.
The differential pressure sensor in Impella RP devices may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I, its most serious category.
Affected product carries product code 0046-0035 and UDI-DI 00813502011869.
Facilities can identify affected devices by the product code and UDI above, and may contact Abiomed, Inc. for further information.
The recalled product
- Product
- Impella RP with SmartAssist. Product Code: 0046-0035.
- Manufacturer
- Abiomed, Inc.
- Affected units
- 291
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 (1)
- Product Code: 0046-0035. UDI-DI: 00813502011869.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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