Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
Abiomed Introducer Kit recalled for sheath leakage risk
Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.
- Contact Abiomed or your healthcare provider immediately if you have received one of the affected pump sets.
- Do not use the affected introducer kit until you receive guidance from Abiomed or your medical team.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2684-2026More Abiomed, Inc. recalls
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