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MICRUSFRAME MFR180714Recalls & 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 7mm (coil diameter) x 14.3cm (coil length) 190cm (working length) · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704078203), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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

  • Failure to Advance1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 29, 2022Failure to Advance; Failure to Advance

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING A BASILAR ANEURYSM, THE PHYSICIAN USED A 7MM X 14.3CM MICRUSFRAME 18 COIL (MFR180714 / 30362738) AS THE FIRST COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE COIL THROUGH AN SL-10® MICROCATHETER (STRYKER) BUT IT DID NOT ADVANCE MORE THAN 20CM (NO FURTHER ADVANCEMENT OF THE DELIVERY WIRE AT THE POINT WHERE THE FLUORO MARKERS MET THE GREEN UNSHEATHING TOOL). THE PHYSICIAN REMOVED THIS COIL AND TRIED WITH TWO 7MM X 30CM MICRUSFRAME 10 COILS (MFR100730) FROM TWO DIFFERENT LOTS (K10620 AND K10276) WITH THE SAME RESULTS. THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE WITH DIFFERENT COILS (A COMBINATION OF STRYKER AND PENUMBRA COILS) USING THE SAME CONCOMITANT SL-10® MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE REPORTED ISSUE RESULTED IN A 20-MINUTE PROCEDURE DELAY THAT WAS NOT DEEMED CLINICALLY SIGNIFICANT. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE INTRODUCERS WERE FLUSHED UNTIL LIQUID WAS VISIBLE A

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14855768 ↗

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