Abiomed Impella CP Introducer Kit Recalled for Thrombus Risk
Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.
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 as Class I, which per the rubric requires a minimum score of 4. Thrombus formation is a serious vascular complication that can result in tissue damage or loss of limb.
Plain-English summary
Abiomed, Inc. is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP (Impella Set Product Code 1000435; Introducer Product Code 1000435) due to potential for thrombus formation during prolonged use of the introducer.
The affected devices consist of 17 units with batch numbers 2038707 and 2045782. Distribution was worldwide, with U.S. distribution in Florida, Illinois, Minnesota, New Jersey, New York, and Virginia, as well as distribution to Japan.
Patients and healthcare providers who have this device should contact Abiomed, Inc. for further guidance. The FDA classified this as a Class I recall.
The recalled product
- Product
- Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- Manufacturer
- Abiomed, Inc.
- Hazard
- Affected units
- 17
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 (5)
- Impella Set Product Code: 1000435
- GTIN: 00813502013009
- Serial Numbers: N/A. Introducer Product Code: 1000435
- Batch Numbers: 2038707
- 2045782.
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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