MICRUSFRAME MFR182050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704078173), received between Dec 20, 2017 and Mar 24, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Separation Failure

  ON (B)(6) 2026, DURING A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) TARGETING THE GASTRIC VEIN, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). THE BRTO WAS CONDUCTED USING A SYSTEM CONSISTING OF A 4FR ANGIOGRAPHIC CATHETER AND THE LEONISMOVA MICROCATHETER. THE GASTRIC VEIN WAS LOOSELY PACKED USING MEDICOS HIRATA COILS DELIVERED WITH THE ¿LEONIS HF.¿ OLDAMIN (UNSPECIFIED DOSAGE) WAS INJECTED, AND ADDITIONAL LOOSE PACKING OF THE PROXIMAL PORTION WAS PLANNED WITH CERENOVUS COILS. THE FIRST COIL WAS A 20MM X 50CM MICRUSFRAME 18 (MFR182050 / 3072525S), AND IT WAS USED AS ANCHOR. PRE-DEPLOYMENT ELECTRICAL CONTINUITY WAS CHECKED, AND AN ATTEMPT WAS MADE TO DETACH THE COIL. IT WAS REPORTED THAT, ¿ALTHOUGH THE USUAL DETACHMENT SOUND WAS HEARD, THE COIL DID NOT DETACH. WHEN THE CABLE WAS RECONNECTED, THE INDICATOR LIGHT DID NOT TURN ON, AND THE DETACHMENT BUTTON COULD NOT BE PRESSED. SINCE THE ISSUE WAS SUSPECTED TO BE ON THE CABLE SIDE, THE [ENPOWER CONTROL CABLE (ECB00018200 / 31127206)] WAS REPLACED, AND DETACHMENT WAS ATTEMPTED AGAIN. AS WITH THE FIRST ATTEMPT, THE INDICATOR LIGHT TURNED ON, AND THE DETACHMENT SOUND WAS HEARD WHEN THE BUTTON WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678333 ↗
• MalfunctionMar 19, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE TARGET LESION AS APPROACHED USING A PARENT PLUS® GUIDE SHEATH (MEDIKIT) AND DOUBLE CATHETERS LANTERN® DELIVERY MICROCATHETER (PENUMBRA) AND LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES). THE TWO MICROCATHETERS WERE ADVANCED INSIDE THE ANEURYSM. WHEN THE 20MM X 50CM MICRUSFRAME 18 (MFR182050 / 31168439) WAS CHOSEN TO BE USED AS A FRAMING COIL VIA THE LIGHTHOUSE MICROCATHETER, RESISTANCE WAS FELT INSIDE THE MICROCATHETER, AND THE COIL COULD NOT BE ADVANCED. CONTINUOUS FLUSH WAS MAINTAINED. THE COIL WAS RETRIEVED AND OBSERVED TO HAVE UNRAVELED. IT WAS REPLACED WITH ANOTHER CERENOVUS COIL OF THE SAME SIZE, WHICH WAS USED WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 11-MAR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL WAS WITHDRAWN ONCE AND WAS NOT REPOSITIONED. PRIOR TO THIS COIL, NO OTHER COIL WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE REPORTED ISSUE OCCURRED DURING INSERTION THROUGH THE MICROCATHETER, BEFORE EXITING THE MICROCATHETER. PER THE INFORMATION, THE MICROCATHETER WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643814 ↗
• MalfunctionMay 10, 2021Separation Failure; Activation Problem; Premature Separation; Separation Failure; Activation Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT SHE WAS ADVISED BY THE HEAD OF THE DEPARTMENT FROM THAT ON (B)(6) 2021, DURING THE TREATMENT OF A CAROTID CAVERNOUS FISTULA, THE 20MM X 50CM MICRUSFRAME 18 COIL (MFR182050 / L13458) MALFUNCTIONED; IT WAS EITHER COIL PREMATURE DETACHMENT OR ISSUE WITH COIL DEPLOYMENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798755 ↗
• InjuryMar 29, 2021Fracture; Difficult to Advance; Premature Separation; Fracture; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM LOCATED AT THE SPLENIC ARTERY, AFTER A 20MM X 50CM MICRUSFRAME S COIL WAS DELIVERED VIA THE CONCOMITANT MASTERS PARKWAY SOFT MICROCATHETER (ASAHI-INTECC) AND SUCCESSFULLY IMPLANTED AS THE FIRST COIL, A 20MM X 50CM MICRUSFRAME 18 COIL (MFR182050 / L13458) WAS THE SECOND COIL SELECTED FOR USE. IT WAS INSERTED INTO THE SAME CONCOMITANT MASTERS PARKWAY SOFT MICROCATHETER, BUT AN INTENSE RESISTANCE WAS ENCOUNTERED WHEN THE COIL SLIGHTLY EXITED THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, BUT THE COIL WAS UNABLE TO BE RETRACTED. THE PHYSICIAN APPLIED SOME FORCE, ¿WHICH BROUGHT FEELING AS IF THE COMPLAINT COIL GOT CUT.¿ THE DELIVERY WIRE WAS REMOVED WITHOUT THE EMBOLIC COIL ATTACHED. THE EMBOLIC COIL THAT REMAINED IN THE MICROCATHETER WAS FLUSHED WITH A SYRINGE; THE COIL CAME OUT OF THE MICROCATHETER AND APPEARED TO BE IMPLANTED IN THE TARGET ANEURYSM. A TORNADO® EMBOLIZATION COIL (COOK MEDICAL) WAS USED AS THE THIRD COIL. THERE WAS A RESISTANCE FELT INSIDE THE MICROCATHETER AND THE COIL FAILED TO ADVANCE. THE MICROCATHETER WAS REMOVED, BUT THE COMPLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582479 ↗
• MalfunctionJan 25, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM, A 24 MM X 60 CM DELTAFILL18 THERMO-MECHANICAL COIL (DLF182460/S13373) WAS FLUSHED AND INSERTED INTO THE 150/5 CM 45TIP PROWLER SELECT PLUS MICROCATHETER (606-S255FX/17665864); HOWEVER, RESISTANCE WAS FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL DELIVERY SYSTEM WAS REMOVED AND FLUSHING LEVEL WAS INCREASED. AFTER THE MICROCATHETER WAS FLUSHED, THE COIL DELIVERY SYSTEM WAS RE-INSERTED BUT STRONG RESISTANCE WAS STILL FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL COULD NOT BE RETRACTED; THEREFORE, THE COIL AND THE MICROCATHETER WERE REMOVED AS A UNIT. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT AND THE COIL WAS REPLACED WITH A 20 MM X 50 CM MICRUSFRAME18 (MFR182050/S14024) THERMO-MECHANICAL COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE MICRUSFRAME18 COIL DELIVERY SYSTEM, BUT THE SHEATH SLIT AND THE PRODUCT COULD NOT BE USED. THE COIL WAS SUBSEQUENTLY REPLACED. IN TOTAL, 20 DELTAFILL COILS WERE IMPLANTED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7218109 ↗
• MalfunctionDec 20, 2017Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM, A MICRUSFRAME 18 (MFR182050/ S13741) SHEATH INTRODUCER SPLIT OPEN EXPOSING THE DELIVERY WIRE AND DURING PRODUCT ANALYSIS, THE COIL WAS FOUND TO BE KINKED. THE SHEATH INTRODUCER WAS INSERTED INTO THE UNSPECIFIED MICROCATHETER AND THE DELIVERY WIRE WAS ADVANCED, BUT THE SHEATH INTRODUCER WAS SPILT OPEN AND THE DELIVERY WIRE EXPOSED. THERE HAD BEEN NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. NO REPORT OF THE OTHER DEVICE USED IN THE PROCEDURE IS AVAILABLE. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133208 ↗