Abiomed Impella CP Introducer Kit recalled for thrombus formation risk
Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.
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 FDA classified this recall as Class I. Per the rubric, FDA Class I recalls must score at least 4 (Severe), and are typically scored 4 or higher given the agency's classification of imminent risk to health.
Plain-English summary
Abiomed, Inc. is recalling the Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP (Impella Set Product Code: 1000434; Introducer Product Code: 1000434; Batch Number: 2038639) due to potential for thrombus (blood clot) formation during prolonged use of the introducer.
A total of 3 units have been distributed. Distribution was worldwide, with U.S. distribution in Florida, Illinois, Minnesota, New Jersey, New York, and Virginia, as well as in Japan.
Patients and healthcare providers who have received this product should contact Abiomed, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
- Manufacturer
- Abiomed, Inc.
- Hazard
- Affected units
- 3
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 (4)
- Impella Set Product Code: 1000434
- GTIN: 00813502012996
- Serial Numbers: N/A. Introducer Product Code: 1000434
- Batch Number: 2038639.
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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