Use cautionMedical device recall · FDA · Published February 2, 2024
Medos CEREBASE DA Guide Sheath Recall: Fractures Risk Surgical Delay and Injury
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.
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Contact the company
📍Recalling firmMedos International SarlChemin Blanc 36 · Le Locle, Switzerland
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/56205-medos-cerebase-da-guide-sheath-recall-fractures-risk-surgical-delay.
“Medos CEREBASE DA Guide Sheath Recall: Fractures Risk Surgical Delay and Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56205-medos-cerebase-da-guide-sheath-recall-fractures-risk-surgical-delay. Based on FDA recall #Z-1284-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1284-2024%22&limit=1).
The FDA announced on Feb. 2, 2024, that Medos International Sarl is recalling CERENOVUS CEREBASE DA Guide Sheaths due to fracture risks. The Class I recall affects 1,343 units distributed worldwide.
How to tell if you have it
Brand: Medos
Product: CERENOVUS CEREBASE DA Guide Sheath
Part Numbers: GS9080SD, GS9090SD, GS9095SD
Units affected: 1,343
The hazard
The FDA said the sheaths may fracture at the distal end, potentially causing surgical procedural delays, vascular injury, or embolism. Medos reported an increase in complaints regarding these fractures.
Context
GovInfoNow's records show Medos International Sarl has one other recall on record since July 23, 2026, involving a software issue with the Velys Robotic-Assist Station. Other recent recalls of similar products include Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026), Merit Medical 16F Dual Valved Splittable Sheath Introducer Recall (Feb. 13, 2026), and Olympus A2642 Inner Sheath Recall (Nov. 11, 2025).
How to tell if you have this one
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.
Brand
Medos
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Part Number
Look for part numbers GS9080SD, GS9090SD, or GS9095SD on the sheath to confirm if it's affected.
Contact Manufacturer
Reach out to Medos International Sarl for further assistance or to confirm if your device is affected.
How this recall unfolded
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1284-2024 (February 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1284-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.