YOGA MC32150ZBXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704081296), received between Feb 1, 2019 and Mar 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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.

• MalfunctionMar 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TREATMENT PROCEDURE THAT WAS TARGETING A GIANT ANEURYSM ON THE RIGHT SUPRAOPHTHALMIC ARTERY, THE YOGA 32 MICROCATHETER (MC32150ZBX / C42462) COULD NOT BE PLACED AS INTENDED DUE TO A REPORTED LACK OF FLEXIBILITY. DUE TO THE LACK OF CATHETER FLEXIBILITY, THE ONLY WAY TO POSITION THE YOGA MICROCATHETER WAS TO PLACE A LOOP OF THE MICROCATHETER INSIDE THE ANEURYSM WHILE PASSING THROUGH ITS NECK, WHICH INCREASED THE DIFFICULTY FOR THE PLACEMENT OF THE 4.5 X 23 MM BRAVO FLOW DIVERTER (FDC4523 / 11017476). THE BRAVO DEVICE WAS DEPLOYED HALFWAY WHEN IT THE INCOMPLETE EXPANSION ISSUE WAS OBSERVED, AND THE BRAVO DEVICE WAS THOUGHT TO HAVE BECOME TWISTED. THE BRAVO DEVICE WAS RECAPTURED WITHOUT ANY ISSUE. THERE WAS NO KNOWN RESISTANCE BETWEEN THE YOGA MICROCATHETER AND THE BRAVO DEVICE. THE DEVICES WERE REMOVED FROM THE PATIENT AS A UNIT; THERE WAS NO DAMAGE OBSERVED ON THE DEVICES, BUT A THROMBUS WAS PRESENT INSIDE THE BRAVO DEVICE. AS A RESULT OF THIS REPORTED ISSUE, THE PHYSICIAN DECIDED TO USE THE DERIVO® EMBOLISATION DEVICE (ACANDIS (B)(4)) AND THE HEADWAY® 27 MICROCATHETER (MICROVENTION). THE PROCEDURE WAS COMPLETED, BUT THERE WAS A RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414685 ↗
• MalfunctionFeb 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A FLOW DIVERSION OF A LARGE CAVERNOUS FUSIFORM RECURRENT ANTERIOR CHOROIDAL ARTERY (ACHA) ANEURYSM, THE YOGA 32 XXB (MC32150ZBX/C42462) MICROCATHETER WAS TRACKED TO THE TARGET ANEURYSM, BUT THE 4.0X27MM BRAVO (FDC4027/11020352) FLOW DIVERTER COULD NOT BE ADVANCED THROUGH THE BODY OF THE MICROCATHETER. THE PHYSICIAN REPORTEDLY EXERTED A LOT OF FORCE IN AN ATTEMPT TO DELIVER THE BRAVO THROUGH THE YOGA, AND EVEN UTILIZED A TORQUE DEVICE, BUT THE BRAVO WOULD NOT EXIT THE MICROCATHETER. THE BRAVO AND YOGA WERE SUBSEQUENTLY RETRIEVED AS A SYSTEM FROM THE PATIENT, RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. UPON REMOVAL OF THE DEVICES, THE WIRE OF THE BRAID AT THE PROXIMAL END OF THE BRAVO WAS NOTED TO HAVE FRAYED. IT WAS STATED THAT ¿EXTENSIVE FORCES WERE APPLIED TO THE DEVICE WHICH CREATED FRICTION AND FRAYING ON DELIVERY WIRE (OUTSIDE THE BODY)¿. THE BRAVO DEVICE WAS STILL ON THE DELIVERY WIRE WHEN REMOVED FROM THE PATIENT. THE DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BRAVO WAS REPLACED WITH A SMALLER BRAVO. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE FIVE-MINUTE DELAY IN PROCEDURE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298149 ↗