Medos recalls CEREBASE DA Guide Sheath models GS9080SD, GS9090SD, GS9095SD due to reported fractures causing surgical delays and vascular injury. Affected units have specific lot numbers and part numbers.
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
Medos is recalling its CEREBASE DA Guide Sheath (part numbers GS9080SD, GS9090SD, GS9095SD) because these devices have been reported to fracture at the distal end, potentially causing surgical delays, vascular injury, or rare embolism. This recall affects medical devices used during vascular procedures.
The sheath can fracture at the distal end during surgical procedures, which may cause delays in surgery, damage blood vessels, or in very rare cases lead to embolism. This happens due to the device's design and usage conditions in medical settings.
Healthcare professionals using the CEREBASE DA Guide Sheath for vascular procedures are most at risk. Patients undergoing surgery with these devices may experience complications if the sheath fractures during use.
Check for part numbers GS9080SD, GS9090SD, or GS9095SD on the sheath. Affected units have specific lot numbers listed in the recall notice, such as 31121042 for model GS9080SD.
Look for part numbers GS9080SD, GS9090SD, or GS9095SD on the sheath to confirm if it's affected.
Reach out to Medos International Sarl for further assistance or to confirm if your device is affected.
Medos has received reports of fractures at the distal end of the CEREBASE DA Guide Sheath, which can cause surgical delays, vascular injury, or rare embolism.
Part numbers GS9080SD, GS9090SD, and GS9095SD are affected, with specific lot numbers listed in the recall notice.
Check the part number on the sheath. Affected units have part numbers GS9080SD, GS9090SD, or GS9095SD and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Medos to request your refund or repair — edit it as you like.
Subject: Recall Z-1284-2024 — Medos Medos Hello, I own a Medos that is covered by recall Z-1284-2024 from Medos. 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.
