MicroPlex Helical Regular 180620HC-R-VRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425025970), received between Dec 30, 2016 and Dec 30, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Separation Failure” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 30, 2016Stretched; Separation Failure; Stretched; Separation Failure

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A LARGE, ACUTE 15MM A-COM ANEURYSM. A DOUBLE MICROCATHETER TECHNIQUE WAS EMPLOYED USING TWO ECHELON-10S (NOT MV), AND A BALLOON WAS PLACED TO ASSIST PRIOR TO COIL PLACEMENT. THE EMBOLIZATION COIL WAS ONE OF FOUR COILS USED AS FRAMING COILS, AND IT WAS POSITIONED TIGHTLY WITHIN THE COIL MASS. THE ATTEMPT TO DETACH THE EMBOLIZATION COIL WAS UNSUCCESSFUL. THE COIL HAD BEEN PRE-TESTED WITH THE CONTROLLER PRIOR TO THE PROCEDURE AND PASSED. ADDITIONAL ATTEMPTS WERE MADE TO DETACH THE COIL USING AN ALTERNATE V-GRIP CONTROLLER, WITHOUT SUCCESS. EVENTUALLY, THE COIL DETACHED; HOWEVER, IT STRETCHED. IV ASPIRIN WAS ADMINISTERED AND THE STRETCHED PORTION OF THE COIL WAS JAILED BY AN ACCLINO STENT. FOUR ADDITIONAL AXIOM COILS (NOT MV) WERE THEN IMPLANTED. FORMATION OF THROMBUS WAS DETECTED WITHIN THE STENT AND REOPRO WAS ADMINISTERED. THROMBUS ASPIRATION WAS PERFORMED THROUGH A SOFIA CATHETER, WITH SOME SUCCESS; HOWEVER, A CT SCAN WAS PERFORMED POST-PROCEDURE, WHICH REVEALED AN INFARCTION. A CRANIOTOMY WAS PERFORMED TO RELIEVE PRESSURE. THE PATIENT CANNOT MOVE HER LEFT SIDE.

  Patient problems: Infarction, Cerebral; Paresis; Thrombus

  MAUDE report 6216729 ↗