CEREPAKTM MDH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10886704084600), received between Jun 12, 2023 and Sep 16, 2025 — classified as 2 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (71 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 2, 2025Open, Classified

   Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

   Z-0434-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN WAS USING A FREEFORM XSFT 4MM X 10 CM COIL (XCR120410, 31112708). HE REPORTED THAT WHEN INSERTING THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) ONTO THE PUSHER WIRE OF THE COIL IT GOT STUCK AND IT WOULD NOT DETACH. HE REMOVED THE COIL AND DETACHER AND USED A NEW 4X10 COIL WITH A NEW DETACHER AND OTHER COILS WITHOUT ANY ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062980 ↗
• MalfunctionSep 4, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO AN UNKNOWN VESSEL, THE PHYSICIAN USED A UNIFORM 4MM X 7.5 CM COIL (FCX100407, 31154117). THEY TRIED TWICE TO DETACH THE COIL WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) AND IT FAILED TO DETACH. ON THIRD TRY, IT SEEMS THE PROXIMAL WIRE OF THE COIL (THE PART INSIDE DETACHER) BROKE OFF. THE COIL DID NOT DETACH, AND THEY TOOK IT OUT OF THE PATIENT. THE PIECE THAT HOSPITAL CLAIMS TO HAVE BROKEN OFF AND THE DETACHER WERE NOT SAVED AND ONLY THE COIL WILL BE RETURNED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-SEP-2025 INDICATED THAT THIS WAS THE FIRST COIL THEY TRIED TO USE. THERE WAS NO RESISTANCE MENTIONED. THERE WAS NO REPORT OF EMBOLIC COIL DAMAGE. THERE WAS NO MENTION OF ANY COMPLEXITY WITH ANATOMY OR PATIENT. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962972 ↗
• MalfunctionSep 2, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE ANTERIOR CEREBRAL ARTERY, A FREEFORM XSFT 3.5MM X 5 CM COIL (XCR123505, 31146338) FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 15-20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-AUG-2025 INDICATED THAT A PROWLER 14 MICROCATHETER WAS USED. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. TWO ATTEMPTS WERE MADE USING THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430). THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE 15 TO 20 MINUTES PROCEDURAL DELAY DID NOT RESULT IN ANY ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939399 ↗
• MalfunctionAug 11, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A TUMOR EMBOLIZATION, A FREEFORM MINI 1MM X 2CM COIL (MCR091020, (B)(6)) DID NOT DEPLOY. LOOSE METAL FRAGMENT AT DISTAL END OF PUSHER. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-AUG-2025 INDICATED THAT AFTER SPEAKING WITH THE ACCOUNT, THIS WAS PROBABLY MORE USER ERROR. THE COIL DID NOT DETACH WHEN THEY TRIED TO USE THE MECHANICAL HANDLE SO THEY ATTEMPTED TO MANUALLY BREAK IT. BUT WHEN THEY DID THAT, THEY DID NOT BREAK IT IN THE CORRECT MANUAL BREAKPOINT. THEY ATTEMPTED TO MANUALLY BREAK IT MORE TOWARDS THE END OF THE PROXIMAL WIRE. THE MANUAL BREAKPOINT WAS INSIDE THE MICRO CATHETER SINCE THEY WERE USING A HEADWAY DUO 160CM MICRO CATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771577 ↗
• MalfunctionAug 6, 2025Activation Problem; Activation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN WAS PERFORMING A PROCEDURE TO EMBOLIZE THE MIDDLE MENINGIAL ARTERY (MMA). THE DOCTOR WAS UTILIZING CEREPAK COILS FOR THE EMBOLIZATION. UPON DEPLOYING A FREEFORM MINI 1MM X 3CM COIL ((B)(6), (B)(6)) INTO THE ARTERY, THE FIRST ATTEMPT TO DETACH THE COIL WAS WITH A MECHANICAL DETACHMENT HANDLE (MDH1,102109430) WHICH WAS UNSUCCESSFUL. AT WHICH POINT THE DOCTOR WAS INSTRUCTED TO PERFORM A MANUAL BREAK TECHNIQUE WHICH WAS ALSO UNSUCCESSFUL. THE DOCTOR REMOVED THE COIL FROM THE MICROCATHETER SUCCESSFULLY AND THE COIL WAS SAVED FOR ANALYSIS. AFTER DEPLOYING 3 OTHER COILS SUCCESSFULLY, ANOTHER FREEFORM MINI 1MM X 3CM COIL ((B)(6), (B)(6)) WAS DEPLOYED AND UPON MECHANICAL HANDLE DETACHMENT BEING UNSUCCESSFUL, AGAIN, THE MANUAL BREAK TECHNIQUE WAS PERFORMED AT WHICH THE PULL WIRE FRACTURED AND COULD NOT BE RETRIEVED THEREFORE RESULTING IN A FAILED DETACHMENT. THE COIL WAS SUCCESSFULLY RETRIEVED THROUGH THE MICROCATHETER, BUT THE DEVICE WAS DESTROYED AND UNABLE TO BE SAVED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2025 CONFIRMED THAT TWO FREEFORM MINI 1MM X 3CM COILS FAILED TO DETACH. A TERUMO HEADWAY DUO 156CM MICROCA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727282 ↗
• MalfunctionAug 1, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM CEREPAK FREEFORM MINI (MCR092535 / 31212048) WAS POSITIONED AND THERE WERE TWO ATTEMPTS TO DETACH IT WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND ONCE VIA MANUAL BREAK. THE COIL FAILED TO DETACH. THE PROCEDURE WAS REPORTEDLY DELAYED BY 15 MINUTES, BUT IT WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A 3.7MM X 3MM X 3MM UNRUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. WHEN THE COIL WAS REMOVED, IT WAS NOT STRETCHED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE CONCOMITANT MICROCATHETER WAS A 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX). THE PROCEDURE WAS COMPLETED WITH 3MM X 6CM CEREPAK FREEFORM XTRASOFT (XCR120306) USING THE SAME 150CM X 50CM PROWLER 14 MICROCATHETER AND THE SAME DETACHMENT HANDLE (THE LOT NUMBER PROVIDED WAS 102109430). THE INFORMATION INDICATED THAT THE PHYSICIAN DID CONSIDER THE 15-MINUTE PROCEDURE EXTENSION TO BE SIGNIFICAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688259 ↗
• MalfunctionJul 21, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY, THE PHYSICIAN ATTEMPTED TO DETACH A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31077163) WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN), HOWEVER FAILED TO DETACH. HE THEN WENT TO MECHANICAL BREAK THAT ALSO FAILED TO DETACH, THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-JUL-2025 INDICATED THAT A PROWLER SELECT LPES MICROCATHETER WAS USED. TWO COILS WERE PREVIOUSLY IMPLANTED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. ONE ATTEMPT WAS USED WITH THE DETACHMENT HANDLE. THERE WAS NO VISIBLE DAMAGE WHEN THEY TOOK THE COIL OUT OF THE HOOP. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR HAD ACUTE BENDS. THERE WAS A THREE-MINUTE PROCEDURAL DELAY WITH NO RESULT OF PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556523 ↗
• MalfunctionJul 15, 2025Activation Problem; Activation Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), A FREEFORM MINI 1MM X 2CM COIL (MCR091020, 31345668) FAILED TO DETACH. MANUAL BREAK WAS ATTEMPTED. THE COIL WAS REMOVED FROM THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JUL-2025 INDICATED THAT A HEADWAY DUO, 156CM MICROCATHETER, WAS USED. FOUR COILS WERE PREVIOUSLY IMPLANTED DURING THE PROCEDURE BEFORE THIS COIL. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THE USER TRIED MANUAL DETACHMENT THEN ATTEMPTED WITH THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE THREE MINUTES PROCEDURE DELAY DID NOT RESULT IN ANY ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509071 ↗
• MalfunctionJul 9, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY, THE DOCTOR TRIED TO DETACH A FREEFORM XSFT 2MM X 2 CM COIL (XCR120202, (B)(6)) WITH THE DETACHER HANDLER AND IT FAILED. HE THEN WENT TO THE MANUAL BREAK AND PULLED 1 CENTIMETER ON THE PULL WIRE THEN RECHECKED WITH FLURO TO SEE IF IT WAS DETACHED AND IT WAS NOT. HE THEN TRIED TO PULL FOR ONE MORE CENTIMETER THEN RECHECKED UNDER FLURO, THE COIL WAS STILL NOT DETACHED AND THEN HE TRIED TO PULL FURTHER AT WHICH POINT HE SAID THAT IT WAS PULLING OUT VERY EASILY, SO HE STOPPED TO FLURO AND THE COIL WAS STILL ATTACHED. THEREFORE, HE REMOVED THE COIL FROM THE PATIENT BECAUSE IT WOULD NOT DETACH. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-JUL-2025 INDICATED THAT A PROWLER SELECT LP-ES MICROCATHETER WAS USED. TWO COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. TWO ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE DEVICE DEFICIENCY DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460062 ↗
• MalfunctionJun 27, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040 / 31434946) DID NOT DETACH. MANUAL DETACHMENT AND WITH THE DETACHMENT HANDLE (MDH1 / 102109430) WERE MADE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 5 MINUTES DUE TO COIL REMOVAL. THERE WAS NO OTHER MEDICAL INTERVENTION, NO NEGATIVE IMPACT ON THE PATIENT. ON 27-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. IT WAS REPLACED WITH ANOTHER 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040). THE PROCEDURE WAS DELAYED BY APPROXIMATELY 3 TO 5 MINUTES. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE CONCOMITANT MICROCATHETER USED WAS THE HEADWAY® DUO 156 MICROCATHETER (TERUMO NEURO). THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 102109430.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347331 ↗
• MalfunctionJun 25, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION OF THE LEFT MIDDLE MENINGEAL ARTERY (MMA), A FREEFORM MINI 1.5MM X 3CMCOIL (MCR091530, 31434948) WAS USED THROUGH A PLATO 17 160CM MICROCATHETER (MC). THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) WAS USED FOR THE FIRST DETACHMENT ATTEMPT. AFTER THE FAILED DETACHMENT ATTEMPT WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS REMOVED WITH SUCCESS. NO PATIENT HARM OR DELAY OF CARE CAME FROM THIS DETACHMENT FAILURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED. MILD TO MODERATE TORTUOSITY WAS NOTED IN LEFT EXTERNAL CAROTID ARTERY (LECA) AND LEFT MIDDLE MENINGEAL ARTERY (MMA). ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT SEVEN COILS WERE PLACED PREVIOUSLY DURING THE PROCEDURE. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333295 ↗
• MalfunctionJun 18, 2025Activation Problem; Activation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA), A HELIFORM XSFT XL 2MM X 4 CM COIL (XHE120204, 31434959) WAS USED THROUGH A PLATO 17 160CM. THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) WAS USED FOR THE FIRST DETACHMENT ATTEMPT. AFTER THE FAILED DETACHMENT ATTEMPT WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS REMOVED SUCCESSFULLY. NO PATIENT HARM OR DELAY OF CARE CAME FROM THIS DETACHMENT FAILURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH THE FIRST TWO CEREPAK COILS. MILD TORTUOSITY WAS NOTED IN THE LEFT EXTRACRANIAL INTERNAL CAROTID ARTERY (LECA) AND THE LEFT MIDDLE MENINGEAL ARTERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-JUN-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE NOTED TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WERE NO PROCEDURAL ELAY/PROLONGATION DUE TO THE EVENT. IT WAS NOTED THAT THE CAUSE OF THE FAILURE TO DETACH IS UNKNOWN. THERE WERE TWO SUCCESSFUL COIL DETACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282736 ↗
• MalfunctionMay 8, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT FIVE CEREPAK UNIFORM COILS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE: UNIFORM 7MM X 30 CM (FCX100730/ 31127140), UNIFORM 7MM X 30 CM (FCX100730/ 31207071), UNIFORM 6MM X 26 CM (FCX100626/ 31177724), UNIFORM 6MM X 26 CM (FCX100626/ 31173105), A UNIFORM XL 5MM X 10 CM (FCX180510/ 31178183), AND A MECHANICAL DETACHMENT HANDLE (MDH1/ LOT # UNKNOWN). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FOR ALL FIVE COILS. THE PHYSICIAN FELT THE FAILURE TO DETACH WAS DUE TO PATIENT TORTUOUS ANATOMY. IT WAS ALSO REPORTED, ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 29-APR-2025. SUMMARY: PER THE INFORMATION, THE MICROCATHETER WAS A PROWLER LPES (PRODUCT CODE/ LOT # UNKNOWN). REGARDING WHAT IS MEANT BY ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE,¿ IT WAS REPORTED,¿ ONE COIL DID DETACH ONCE THE SYSTEM RELAXED AND WAS NOT UNDER SO MUCH TENSION.¿ ONE COIL WAS SUCCESSFULLY IMPLANTED DURING THIS CASE. REGARDING WHETHER RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICES THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM, IT WAS REPORTED, ¿MUCH TENSIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987692 ↗
• MalfunctionMay 2, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953947 ↗
• MalfunctionMay 2, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953743 ↗
• MalfunctionMay 1, 2025Activation Problem; Activation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA), A FREEFORM XSFT 6MM X 10 CM COIL (XCR120610, 31173119) FAILED TO DETACH. A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) FAILED. THE COIL WAS REMOVED WITHOUT INCIDENT. REPLACED WITH A CEREPAK FF XSFT 4X10 COIL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-APR-2025 INDICATED THAT A SL-10 MICROCATHETER (MC) WAS USED. TWO COILS WERE PREVIOUSLY IMPLANTED. THE MICROCATHETER WAS RE POSITIONED. THE COIL WAS BEING PLACED IN A TIGHT AREA WITH SOME MICROCATHETER KICK BACK. THERE WAS NO PROBLEM WITH ADVANCEMENT IN THE MICROCATHETER. TWO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. THERE WAS NO VISIBLE DAMAGE TO THE EMBOLIC COIL. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN MENTIONED THAT THE FORCE USED TO GET THE COIL INTO PLACE ALONG WITH THE MICROCATHETER KICK BACK COULD HAVE BEEN A FACTOR IN THE FAILURE TO DETACH. THE PROCEDURE WAS DELAYED BY 3 TO 4 MINUTES, WITH NO CLINICAL SIGNIFICANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942342 ↗
• MalfunctionApr 28, 2025Activation Problem; Activation Problem

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN USED A CEREPAK FREEFORM MINI (MCR091540) WITH NO ISSUE WITH DETACHMENT. THEN A SECOND FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED. THE OPERATING ROOM (OR) TECHNICIAN USED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND THE COIL DIDN¿T DETACH. A 3RD FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED, AND THIS TIME THE PHYSICIAN FIRST USED A MECHANICAL DETACHER, IT FAILED. THEN TRIED A MANUAL METHOD AND IT AGAIN FAILED TO DETACH THE COIL. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2025 INDICATED THAT A HEADWAY DUO 156CM MICROCATHETER WAS USED. NEITHER THE TECH NOR PHYSICIAN EXPRESSED ANY PARTICULAR OR DIFFICULTY IN ADVANCEMENT OR POSITIONING THE COILS. THE PACKAGING OF THE COILS WAS INTACT AND IN PROPER SEALING. THE COILS ITSELF WERE HANDED OVER TO THE TECH AND AS FAR AS WE COULD SEE THERE WAS NO ISSUE IN THAT REGARD. THE VESSEL WAS EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN DOES NOT KNOW EXACTLY WHY THE EVENT HAPPENED, ¿MAYBE IT WAS HIS FIRST TIME USING OUR COILS ON PATIENTS¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918172 ↗
• InjuryApr 28, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A FREEFORM XSFT 3MM X 8 CM (XCR120308/ 31162597) AND A MECHANICAL DETACHMENT HANDLE (MDH1/ 102109430) WERE USED FOR AN ENDOVASCULAR COILING PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED COIL- FAILURE TO DETACH AFTER ATTEMPTING TO USE THE HANDLE DETACHER TWICE AND MANUAL BREAK ONCE. THE PHYSICIAN THEN DECIDED TO REMOVE THE COIL, HOWEVER, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER UPON REMOVAL. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO ASPIRATE COIL OUT OF MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED AND THE PHYSICIAN WAS REQUIRED TO REENGAGE THE ANEURYSM. THE SURGERY WAS DELAYED BY 45 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ON 23-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED. SUMMARY: THE TARGET TREATMENT SITE WAS AN UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY BIFURCATION. VESSEL CHARACTERISTICS WERE DESCRIBED AS ¿MILD TORTUOSITY.¿ THE 45-MINUTE DELAY WAS CONSIDERED TO BE CLINICALLY SIGNIFICANT ¿BECAUSE MICROCATHETER HAD TO BE REMOVED AND ANEURYSM HAD TO BE RE ENGAGED.¿ WHEN REMOVED, THE COIL DID NOT APPEAR TO BE STRETCHED OR DAMAGED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917920 ↗
• MalfunctionApr 21, 2025Activation Problem; Activation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A TUMOR EMBOLIZATION, A FREEFORM MINI 2MM X 4CM COIL (MCR092040, 31098100) FAILED TO DETACH. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-APR-2025 INDICATED THAT THE COIL DID NOT DETACH AFTER ATTEMPTING TO USE THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) OR MANUAL BREAK ATTEMPT. THERE WERE NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS (CALCIFICATION/TORTUOSITY). THE PROCEDURE WAS COMPLETED BY USING ANOTHER CEREPAK COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874465 ↗
• MalfunctionApr 21, 2025Activation Problem; Activation Problem

  AS REPORTED BY THE HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO A VERTEBRAL ARTERY FISTULA, THE PHYSICIAN WAS COILING THROUGH A PLATO 017 160CM MICROCATHETER (MC). INSERTED 10 COILS PREVIOUSLY. INSERTED A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339), DURING DETACHMENT, TRIED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) BUT WAS UNSUCCESSFUL SO THE USER TURNED TO MANUAL BREAK METHOD. DURING MANUAL BREAK, PULL WIRE BROKE OFF INSIDE OF THE PUSHER TUBE, SO UNABLE TO GRASP WITH HEMOSTAT TO PULL ON THE PULL WIRE. THE COIL WAS UNABLE TO DETACH. 5 COILS WERE SUBSEQUENTLY IMPLANTED AND DETACHED WITH NO ISSUES. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO VISUAL DEFORMITIES ON THE COIL. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. IN THE PHYSICIAN'S OPINION, THERE WERE NO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872796 ↗
• MalfunctionMar 13, 2025Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A LARGE CAVERNOUS ANEURYSM 21X18, FLOW DIVERTER WAS PLACED IN RIGHT INTERNAL CAROTID ARTERY (RICA). THE SL-10 MICROCATHETER WAS JAILED IN ANEURYSM. A UNIFORM XL 20MM X 50 CM COIL (FCX182050, (B)(6)) DEPLOYED AND ATTEMPT TO DETACH WITH MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) BUT FAILED TWICE. ATTEMPTED MANUAL BREAK, HOWEVER, IT ALSO FAILED. THE COIL WAS PULLED OUT WITH NO PROBLEM AND A NEW 18MM X 46CM CEREPAK UNIFORM DETACHED WITH MECHANICAL HANDLE. NEXT, A COIL 16MM X47CM WAS ALSO PLACED AND DETACHED WITH HANDLE. THEN, A UNIFORM XL 14MM X 47 CM COIL (FCX181447, (B)(6)) WAS PLACED AND DETACHMENT FAILED WITH TWO ATTEMPTS. MANUAL BREAK WAS ATTEMPTED BUT ALSO FAILED AND COIL HAD TO REMOVE WITHOUT INCIDENT. THE DOCTOR USED A NON-J&J COIL AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS FINE IN POST-OP. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-MAR 2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COILS OR ANY DEVICE COMPONENT. THERE WAS SOME VESSEL TORTUOSITY BUT NOT SEVERE. THE PROCEDURE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596499 ↗
• MalfunctionMar 10, 2025Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION, A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339) DID NOT DETACH WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, UNKNOWN LOT), IT ALSO DID NOT DETACH MANUALLY. THE DOCTOR RETRIEVED THE COIL WITH NO PROBLEMS. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-FEB-2025 INDICATED THAT THREE COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THREE ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE. IT WAS NOTED THAT THE PULL WIRE OF THE DEVICE WAS STRETCHED. THERE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 CONFIRMED THAT THE COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561325 ↗
• MalfunctionMar 4, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, TWO COILS (CATALOG AND LOT NUMBERS UNKNOWN AT THE TIME OF THE COMPLAINT INITIATION) FAILED TO DETACH. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON 25-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET WAS AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM (NOT SURE WHICH SIDE ¿ LEFT OR RIGHT). THE INFORMATION INDICATED THAT IT IS POSSIBLE NO OTHER MEANS OF DETACHMENT WERE ATTEMPTED. IT DOES NOT APPEAR THAT ALTERNATIVE METHODS TO DETACH WERE TRIED, ¿BUT NOT SURE.¿ THE DETACHMENT HANDLE IS NOT AVAILABLE. THE LOT NUMBER OF THE DETACHMENT HANDLE (MDH1) IS NOT AVAILABLE. THE HANDLE WAS USED WITH BOTH COILS. THE TWO COILS USED WERE A 4MM X 7CM CEREPAK FREEFORM (SCR120407 / 31149189) AND A 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31484772). THE COILS WERE NOT REPLACED; INFORMATION ON HOW THE PROCEDURE WAS COMPLETED WAS NOT PROVIDED. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION BECAUSE OF THE REPORTED ISSUE. THE INFORMATION CONFIRMED NO NEGATIVE PATIENT IMPACTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521025 ↗
• MalfunctionFeb 13, 2025Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410) FROM THE SAME LOT NUMBER (31218776) DID NOT DETACH WITH THE DETACHMENT HANDLE (MDH1 / 102109430) OR VIA MANUAL BREAK. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 05-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE PROCEDURE WAS A VESSEL SACRIFICE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY. THE VESSEL MEASURED 3.5MM. BOTH COILS WERE CONFIRMED TO BE FROM THE SAME LOT (31218776). THE LOT NUMBER OF THE DETACHMENT HANDLE IS 102109430. THE SAME HANDLE WAS USED WITH BOTH COILS, AND IT IS NOT AVAILABLE FOR RETURN. WHEN THE COILS WERE REMOVED, THEY WERE NOT STRETCHED; BOTH COILS WERE DETACHED, ONE HAD THE DETACHMENT WIRE STILL ON IT. THE CONCOMITANT MICROCATHETER WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COIL. THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376554 ↗
• MalfunctionFeb 13, 2025Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A FREEFORM MINI 2MM X 3CMCOIL (MCR092030, 31077163) DID NOT DETACH WHILE TRYING TO COIL THE LEFT MIDDLE MENINGEAL ARTERY (MMA) TRUNK. THREE ATTEMPTS WERE UNSUCCESSFUL WHILE USING A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430). THE PHYSICIAN THEN REMOVED THE COIL AND PROCEEDED TO FINISH COILING WITH NEW FREEFORM MINI COILS. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED INDICATING THAT AN ECHELON 10 MICROCATHETER (MC). FOUR COILS WERE PREVIOUSLY IMPLANTED DURING THE PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THE TECHNICIAN REPORTED THAT SHE WAS PLACING THE COIL IN THE HOOP AFTER FAILED IMPLANTATION AND SHE BENT THE SHAFT. THERE WAS NO VESSEL EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375726 ↗