ABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
Abiomed is recalling ABIOMED Introducer Kit 23 Fr due to potential sheath leakage from manufacturing defects. The leakage risk is not visually detectable and affects all current batches worldwide.
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: This is an FDA Class I recall of a critical medical device (heart pump accessory). Class I recalls carry a score of at least 4; the potential for fluid leakage in a heart pump system poses significant risk of patient harm.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Introducer Kit 23 Fr, 11 cm (Pump Set Code 1000441, Introducer Product Code 2000342). The recall affects 196 units distributed worldwide, including throughout the US, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Japan, Mexico, the Netherlands, Spain, the United Kingdom, and many other countries.
The introducer sheaths may leak from under the sheath cap and along the hub score lines due to manufacturing issues. These defects are not visually detectable by users. The 23 Fr Introducer is included in every pump set.
Patients and healthcare providers should contact Abiomed, Inc. for instructions on returning the affected kits or obtaining replacements. Do not use the recalled introducer kits if you suspect leakage or damage.
The recalled product
- Product
- ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 196
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)
- Pump Set Code 1000441
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.
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