Kalila Medical recalls Vado Steerable Sheath 8.8F (REF SS8FMU67) due to potential torn liner material from manufacturing defects. Affected units were shipped 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 Steerable Sheath 8.8F (REF SS8FMU67) because internal testing found torn liner material at the proximal end, which could be caused by manufacturing defects. This issue may lead to complications during medical procedures if the sheath is used without proper integrity.
The sheath liner material may tear during manufacturing, potentially compromising the device's integrity. If the liner tears, it could cause the sheath to malfunction during medical procedures, leading to complications.
Medical professionals using this device for procedures are likely affected. Patients receiving the device during procedures may be at risk if the sheath fails.
Check for the model number SS8FMU67 on the product label. The device was packaged in a lidded tray within a pouch inserted into a shelf carton. Lot numbers 0559 (expiring 10/9/2018) and 0571 (expiring 10/19/2018) are associated with this recall.
Look for the model number SS8FMU67 and lot numbers 0559 or 0571 on the device packaging.
The recall states that torn liner material was detected during internal testing, but the device is not inherently dangerous if used correctly. The risk is related to potential manufacturing defects.
The recall does not specify a remedy, so no action is required. Check the product label for the model number and lot numbers to confirm if it is affected.
The device was manufactured with lot numbers 0559 (expiring 10/9/2018) and 0571 (expiring 10/19/2018).
We’ve drafted a message you can send Kalila Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0563-2018 — Kalila Medical Kalila Medical Hello, I own a Kalila Medical that is covered by recall Z-0563-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
