Kalila Medical recalls Vado Bi-Directional Steerable Sheath 8.8F (REF SS8FMB74) due to potential torn sheath liner from manufacturing defects. Affected units were sold with specific lot numbers and expiration dates.
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
Kalila Medical is recalling Vado Bi-Directional Steerable Sheath 8.8F (REF SS8FMB74) because internal testing found torn sheath liner material at the proximal end, which could result from manufacturing defects. This issue may cause complications during medical procedures if the sheath is used without proper integrity.
The sheath liner material can tear during manufacturing, potentially compromising the device's structural integrity. This could lead to improper function or unintended complications during medical procedures if the sheath is used without the liner being intact.
Medical professionals using this specific sheath during procedures are most at risk. Patients receiving this device as part of their treatment may also be affected if the sheath fails during use.
Check for the model number SS8FMB74 on the label. The product was sold with lot numbers 0594 (expiring 1/19/2018) and 0626 (expiring 04/23/2018) in sterile packaging.
Look for the model number SS8FMB74 and lot numbers 0594 or 0626 on the label.
The recall indicates potential torn sheath liner material from manufacturing defects, so it is not recommended for use until the manufacturer confirms it is safe.
The recall does not specify a remedy, so contact Kalila Medical directly for guidance on next steps.
The product was sold with specific lot numbers and expiration dates: lot 0594 expiring 1/19/2018 and lot 0626 expiring 04/23/2018.
We’ve drafted a message you can send Kalila Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0564-2018 — Kalila Medical Kalila Medical Hello, I own a Kalila Medical that is covered by recall Z-0564-2018 from Kalila Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
