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MICRUSFRAME MFR181750Recalls & reported problems

Cerenovus, Inc. · MICRUSFRAME S Microcoil 18 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: MICRUSFRAME S 18 Stretch Resistant Coil 17mm (coil diameter) x 50cm (coil length) 190cm (working length) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704078142), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Migration1
  • Premature Separation1
  • Stretched1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 3, 2019Stretched; Migration; Premature Separation; Stretched; Migration; Premature Separation

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PIPELINE-ASSISTED COIL EMBOLIZATION OF A 19MM X 17MM INTRACRANIAL ANEURYSM, THE PHYSICIAN ADVANCED THE MICROCATHETERS INTO THE INTERNAL CAROTID ARTERY (ICA); THE PIPELINE DEVICE WAS PRELOADED IN THE PHENOM¿ .027 MICROCATHETER (MEDTRONIC), THE 17MM X 50CM MICRUSFRAME 18 COIL (MFR181750 / L12470) WAS ADVANCED INTO THE TARGET ANEURYSM VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC) BUT THE PHYSICIAN WAS UNABLE TO ADVANCE THE ENTIRE COIL INTO THE ANEURYSM. TWO ATTEMPTS WERE MADE TO ADVANCE THE COIL WITHOUT SUCCESS. AS A RESULT, THE PHYSICIAN DECIDED THE PULL THE COIL OUT, BUT THE COIL BECAME DETACHED FROM THE PUSHER WIRE AT THE DETACHMENT ZONE LEAVING THE COIL HANGING FROM THE ANEURYSM WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL INTO THE MICROCATHETER. THERE WAS NO REPORT OF BLOOD FLOW REDUCTION OR RESTRICTION AS A RESULT OF THE EVENT. THE PIPELINE DEVICE WAS RESHEATHED AND REMOVED FROM THE PATIENT. AN AMPLATZ GOOSE NECK¿ MICRO SNARE (MEDTRONIC) WAS USED TO RETRIEVE THE COIL. ADDITIONAL EVENT INFORMATION RECEIVED CONFIRMED THAT THE COIL LOOKED STRETCHED ONCE IT WAS REMOVED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS AS A RESULT OF

    Patient problems: No Code Available

    MAUDE report 8957755 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.