Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
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 with medical devices carry a minimum severity of 4 (Severe), particularly where a critical device failure (sheath leakage) could compromise device function in a high-risk cardiac application without visible warning to the user.
Plain-English summary
Abiomed, Inc. is recalling the Impella 5.5 SmartAssist S2 Set, Pump Set Codes 1000459 and 1000460, containing Introducer Product Code 0052-3006-JP. Approximately 1,574 units have been distributed worldwide, including across the US and to 34 other countries and territories.
The recall addresses a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in both the 14Fr and 23Fr introducers. These manufacturing defects are not visually detectable by the user. Because 14Fr or 23Fr introducers are provided in every pump set, all current field batches are affected.
Patients and healthcare providers with affected devices should contact Abiomed, Inc. directly for guidance on next steps. The FDA classified this as a Class I recall. This is a serious matter requiring prompt action.
The recalled product
- Product
- ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 1,574
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 (2)
- Pump Set Codes 1000459
- 1000460
Distribution
Part of a larger recall action
This product is one of 13 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 13 products in this recall →Related recalls
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