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# Medos Guide Sheath Recall is Class 1: FDA
- URL: https://www.fdaweb.com/medos-guide-sheath-recall-is-class-1-fda/
- Published: 2024-04-04T12:00:00.000Z
- Updated: 2026-09-14T14:27:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156706

FDA says the 2/2 Medos International Sàrl recall of the Cerenovus Cerebase DA guide sheath neurovascular catheter is Class 1\. The company recalled 1,343 devices in the U.S.

An FDA [notice](https://www.fda.gov/medical-devices/medical-device-recalls/medos-international-sarl-recalls-cerenovus-cerebase-da-guide-sheath-due-cracking-distal-catheter?ref=fdaweb.com) says the company recalled the sheaths after complaints describing fractures of the distal catheter shaft. Using the affected product may result in surgical procedure delay, vascular injury or hemorrhage, and in extremely rare cases may result in embolism, FDA says. It says there have been three reported injuries and no deaths associated with the units.