MicroPlex Helical Soft 180208HC-S-VRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425025895), received between Jul 12, 2016 and Jul 12, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED FROM (B)(6) THAT DURING THE COIL EMBOLIZATION TREATMENT OF A LMCA (LEFT MAIN CORONARY ARTERY), THE LAST COIL WAS POSITIONED WITHIN THE ANEURYSM SAC. UPON DEPLOYMENT, THE COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO REMOVE THE COIL HOWEVER, THIS WAS UNSUCCESSFUL DUE TO THE COIL MASS. MULTIPLE DETACHMENT ATTEMPTS WERE MADE USING THE V-GRIP CONTROLLERS. ON THE 11TH ATTEMPT, THE COIL DETACHED, HOWEVER ANEURYSM PERFORATION OCCURED CAUSING BLEEDING. REMEDIAL ACTION TAKEN: PHARMACEUTICAL COMA WITH FULL MONITORING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 5787699 ↗