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MICRUSFRAME MFR181550Recalls & 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 15mm (coil diameter) x 50cm (coil length) 190cm (working length) · Class 2 · Implant

All models of MICRUSFRAME (47)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704078128), received between Jan 22, 2020 and Dec 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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

Device problems

  • Premature Separation1
  • Unraveled Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 1, 2020Premature Separation; Premature Separation

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, K10194) WAS BEING USED AS A FRAMING COIL. THE DELIVERY WIRE WAS ADVANCED BUT THERE WAS A RESISTANCE FELT AND IT WAS NOT ABLE TO MOVE. THE PHYSICIAN ATTEMPTED TO REMOVE THE 15MM X 50CM MICRUSFRAME18 COIL BUT IT PREMATURELY DETACHED. HOWEVER, THE USER WAS ABLE TO REMOVE THE COIL FROM THE PATIENT. IT WAS REPLACED WITH ANOTHER 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, L16935) BUT THERE WAS ALSO A RESISTANCE FELT. IT WAS ATTEMPTED TO BE RE-SHEATHED BUT THE SHEATH GOT DAMAGED. IT WAS REPLACED WITH ANOTHER COIL AND FRAMING WAS DONE. ANOTHER SMALLER PRESIDIO COIL, COMPETITIVE COILS AND TWO DELTAFILL18 COILS WERE IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10929461 ↗
  • MalfunctionJan 22, 2020Unraveled Material; Unraveled Material

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A PANCREATIC ARCADE ANEURYSM AND LAPPING, A 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, L11488) WAS USED. THE POSITION OF A CONCOMITANT MICROCATHETER (CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) WAS UNSTABLE. THE COMPLAINT COIL WAS ATTEMPTED TO BE RE-SHEATHED BUT THE SHEATH WAS NOT ABLE TO BE MADE EVEN THE RE-SHEATH TOOL WAS RETRACTED. THE COMPLAINT COIL WAS NOT ABLE TO BE RE-SHEATHED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE COIL UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE CONTINUED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE MICROCATHETER WAS UNSTABLE DUE TO UNSTABLE AS THE MEMORY OF THE COIL WAS STRONG. IT IS UNKNOWN IF THERE WAS COIL POSITIONING DIFFICULTIES. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9616327 ↗

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Sources and updates

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