MICRUSFRAME MFR180933Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704078234), received between Mar 24, 2017 and Jun 16, 2022 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionJun 16, 2022Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTERVENTIONAL EMBOLIZATION PROCEDURE OF AN ANEURYSM, DURING THE ATTEMPT TO POSITION A 9MM X 33CM MICRUSFRAME 18 COIL (MFR180933 / 30404330), ¿THE DETACHMENT OF THE PUSHER OCCURRED WHILE THE COIL WAS STILL PARTIALLY POSITIONED AND WITHOUT ANY HYDRO ELECTROLYTIC COMMAND FOR THE OPERATOR.¿ THE COIL WAS INSERTED INTO THE ANEURYSM. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721691 ↗
• InjuryNov 3, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  A REPORT FROM THE FIELD INDICATED THAT AN UNSPECIFIED CERENOVUS MICROCOIL (UNKNOWN PRODUCT CODE & LOT NUMBER) BROKE INTO TWO DURING THE PROCEDURE RESULTING IN A SURGICAL DELAY. THE PHYSICIAN HAD TO USE A STENT RETRIEVER TO RECOVER THE COIL AS IT WAS "HANGING" IN THE VESSEL. THE INCIDENT WAS RECTIFIED WITH NO REPORTED PATIENT INJURY. PRODUCT AVAILABILITY IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION. ADDITIONAL INFORMATION RECEIVED ON 19-OCT-2020 INDICATED THAT THE COMPLAINT COIL WAS A 9MM X 33CM MICRUSFRAME18 (MFR180933/L10602). THE TARGET ANEURYSM WAS LOCATED AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). RESISTANCE WAS FELT ON THE THIRD DEPLOYMENT OF THE COIL. THE COIL ¿SNAPPED¿ INTO TWO PIECES. THEREFORE, THE BROKEN COIL WAS REMOVED FROM THE PATIENT USING A TREVO STENT RETRIEVER. IT WAS SUCCESSFULLY REMOVED AFTER THREE RETRIEVAL ATTEMPTS INTO THE BALLAST (BALT) LONG GUIDE SHEATH. NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. TWO SCEPTER XC (MICROVENTION) BALLOON CATHETERS AND AN ECHELON 10 (MEDTRONIC) MICROCATHETER WERE USED IN CONJUNCTION WITH THE COMPLAINT COIL. IT WAS NECESSARY TO REMOVE THE CONCOMITANT DEVICES WITH THE COMPLAINT COIL. THE

  Patient problems: No Code Available

  MAUDE report 10778170 ↗
• MalfunctionApr 6, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 9MM X 33CM MICRUSFRAME18 COIL (MFR180933, L14372) WAS USED AS THE FRAMING COIL BUT IT WAS NOT WINDED AS INTENDED. THE PHYSICIAN WENT DOWN THE ZIPPER TO RE-SHEATH THE COMPLAINT COIL, HOWEVER, THE SHEATH INTRODUCER GOT DAMAGED AND IT WAS NOT ABLE TO BE RE-SHEATHED. IT WAS REPLACED WITH A COMPETITOR¿S (CASHMERE) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PROLONGATION OF THE PROCEDURE DUE TO THE EVENT. NO EXCESSIVE FORCE WAS APPLIED DURING UNSHEATHING OR RESHEATHING. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928274 ↗
• MalfunctionApr 17, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET TREATMENT OF A BASILAR TIP ANEURYSM, THE PHYSICIAN USED THE SL-10® MICROCATHETER (STRYKER) TO GAIN ACCESS TO THE ANEURYSM AND INTRODUCED THE 9MM X 33CM MICRUSFRAME 18 COIL (MFR180933 / L11483) THROUGH THE MICROCATHETER. NO FRICTION WAS NOTED. HOWEVER, AS THE DISTAL TIP OF THE COIL REACHED THE LEVEL OF THE PROXIMAL COILING MARKER ON THE MICROCATHETER TIP, THE PHYSICIAN NOTED FRICTION AND REPORTED THAT HE COULD NOT ADVANCE THE COIL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL BUT SUSPECTED THAT THE COIL WAS STUCK. AS A RESULT, THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT AND THEN AGAIN ATTEMPTED TO PULL THE COIL OUT OF THE MICROCATHETER AND AS HE DID, HE FELT A SUDDEN GIVE AND IT APPEARS THAT THE DEVICE POSITIONING UNIT (DPU) WAS PULLED OUT OF THE MICROCATHETER, BUT THE COIL DETACHED AND REMAINED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT AT NO POINT DID THE COIL EXIT THE MICROCATHETER WHILE INSIDE THE PATIENT. WHEN THE MICROCATHETER WAS REMOVED, THERE WAS NO KINK OR OTHER DAMAGES NOTED ON IT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR PROCEDURAL DELAY. THE PROCEDU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523872 ↗
• MalfunctionJan 2, 2019Off-Label Use; Positioning Problem; Off-Label Use; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INFERIOR MESENTERIC ARTERY (IMA) ANEURYSM, THE 9MM X 33CM MICRUSFRAME18 (MFR180933/S13598) THERMO-MECHANICAL COIL WAS DELIVERED TO THE TARGET LESION, BUT ¿IT COULD NOT MAKE AN ANCHORING¿. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL, BUT THE DELIVERY WIRE BECAME EXPOSED FROM THE SHEATH AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED. LATER, THE 7MM X 21CM GALAXY G3 (GLY120721/L12844) THERMO-MECHANICAL COIL WAS SELECTED FOR USE BUT THE SAME ISSUE OCCURRED. THE SHEATH BECAME DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN ENPOWER (DCB2000500) DETACHMENT CONTROL BOX WAS USED IN THE CASE. THE PRODUCTS WILL B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210721 ↗
• MalfunctionMar 24, 2017Difficult To Position; Physical Resistance; Difficult To Position; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A MICRUSFRAME (MFR180933/ C41983) PROTRUDED FROM THE ANEURYSM AND KICKED THE STRYKER SL-10 STRAIGHT MICROCATHETER FROM THE ANEURYSM. THE DEVICE WAS USED TO FRAME A 9MM MIDDLE CEREBRAL ARTERY ANEURYSM. THE COIL WAS POSITIONED INTO THE ANEURYSM AS THE FIRST FRAMING COIL. THE COIL WAS DEPLOYED AS IT SHOULD, CREATING A NICE FRAME, BUT THE LAST 1-2CM WOULD NOT STAY IN THE ANEURYSM. THE PHYSICIAN ATTEMPTED SIX TO EIGHT TIMES TO PULL BACK THE COIL INTO THE MICROCATHETER TO RE-POSITION THE MICROCATHETER TIP AND THEN CONTINUED TO DEPLOY THE COIL HOWEVER, AFTER THESE MANY ATTEMPTS, THE LAST 1 -2CM OF THE COIL WOULD NOT STAY POSITIONED IN THE ANEURYSM, THUS KICKING THE MICROCATHETER OUT OF THE ANEURYSM EACH TIME. THE COIL PROTRUSION DID NOT RESTRICT CEREBRAL BLOOD FLOW OR RESULT IN PATIENT INJURY. THE COIL WAS THEN PULLED OUT OF THE ANEURYSM, AND WAS NOT USED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THERE HAD BEEN NO RESISTANCE WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY COILING THE ANEURYSM WITH COILS UNTIL DESIRED PACKING DENSITY. THE EVENT DID NOT RESULT IN A PROCEDURE DELAY. THE D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6431478 ↗