YOGA MC28150ZBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704079415), received between Sep 10, 2018 and Nov 15, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A FLOW DIVERSION OF A RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE YOGA 28 XB (MC28150ZB/C42465) MICROCATHETER WAS ADVANCED SUCCESSFULLY PASSED THE ANEURYSM LOCATION, BUT THE BRAVO FLOW DIVERTER (FDC4023/UNK LOT) CAME TO A STOP AT THE CAROTID SYPHON IN THE YOGA MICROCATHETER. THE PHYSICIAN REPLACED THE YOGA 28 MICROCATHETER WITH A YOGA 32 MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. IT WAS NOT REPORTED WHETHER THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073977 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A FLOW DIVERSION OF A RIGHT INTERNAL CAROTID ARTERY ANEURYSM, WHILE MANIPULATING THE YOGA 28 150 CM XB (MC28150ZB/C42465) MICROCATHETER TO OPTIMIZE DISTAL TIP PLACEMENT FOR DEPLOYMENT OF A 3.5 X 15 MM BRAVO (FDC3515/11031489) FLOW DIVERTER DEVICE, THE PATIENT EXPERIENCED SIGNIFICANT VASOSPASM. THE PHYSICIAN STOPPED MANIPULATING THE SYSTEM AND ADMINISTERED A DOSE OF INTRA-ARTERIAL NIMODIPINE (1.8 MG) AND LEFT THE SYSTEM IN PLACE. AFTER 30 MINUTES, THE PHYSICIAN EVALUATED THE RESPONSE AND REPEATED THE DOSE NIMODIPINE DUE TO THE PERSISTENT VASOSPASM. THE VASOSPASM DID NOT IMPROVE AFTER 30 MINUTES SO THE PHYSICIAN REMOVED THE SYSTEM FROM THE VASCULATURE AND REPEATED THE DOSE OF NIMODIPINE. THIRTY MINUTES LATER, THE VASOSPASM RESOLVED (TOTAL OF 90-MINUTE DELAY RELATED TO VASOSPASM). THE PHYSICIAN INTRODUCED THE SYSTEM AGAIN AND ALTHOUGH SOME VASOSPASM WAS EVIDENT, IT WAS NOT SIGNIFICANT ENOUGH TO PRODUCE ADDITIONAL DELAY. THE PHYSICIAN COMMENTED THAT THE YOGA CATHETER MAY BE EASIER TO MANIPULATE WITH A LONGER DEVICE AND DECIDED TO COMPLETE THE PROCEDURE WITH A 3.5 X 23 MM BRAVO. THE PATIENT WAS UNDER ANESTHESIA AND WAS STABLE DURING THE P

  Patient problems: Vasoconstriction

  MAUDE report 7862332 ↗