Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall
Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.
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 has classified this as a Class I recall. Class I recalls are by definition for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the severity rubric, FDA Class I recalls are never below score 4.
Plain-English summary
Abiomed, Inc. is recalling the Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits in 13 and 25 cm sizes. Product Code 1000542, Batch Number 2041530, Lot GTIN 813502013467. The recall affects 7 units distributed nationwide in Florida, Illinois, Minnesota, New Jersey, New York, Virginia, and Japan.
The reason for this recall is a potential for thrombus (blood clot) formation during prolonged use of the introducer. This is a Class I recall by the FDA.
Healthcare facilities and providers in affected areas that have received this product should stop use immediately and contact Abiomed, Inc. for additional information and instructions regarding return or replacement of the affected introducer kits.
The recalled product
- Product
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- Manufacturer
- Abiomed, Inc.
- Affected units
- 7
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: 1000542
- GTIN: 813502013467
- Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542
- Batch Number: 2041530.
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.
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