CEREPAK FREEFORM XCR120308Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704083658), received between Jan 2, 2024 and Apr 28, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 2, 2025Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2025Separation Failure; Premature Separation; Separation Failure; Premature Separation

  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 21917898 ↗
• MalfunctionDec 13, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION PROCEDURE TARGETING AN ARTERIAL FEEDING OF AN ARTERIOVENOUS MALFORMATION (AVM) WITH NOTED MILD TORTUOSITY IN THE RIGHT EXTERNAL CAROTID ARTERY (ECA), A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / 31406457) WAS USED THROUGH THE HEADWAY® 17 MICROCATHETER (TERUMO NEURO) WITH CONTINUOUS FLUSH MAINTAINED. THE DETACHMENT HANDLE (MDH1 / LOT#: UNKNOWN) WAS USED FOR THE FIRST TWO DETACHMENT ATTEMPTS. AFTER THE FAILED DETACHMENT ATTEMPTS, THE MANUAL BREAK METHOD WAS USED UNSUCCESSFULLY. THE COIL WAS REMOVED, AND ANOTHER COIL OF THE SAME SIZE WAS USED WITH SUCCESS. THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THE ARTERIAL FEEDER TO THE AVM WAS SUCCESSFULLY EMBOLIZED WITH THREE MORE CEREPAK COILS. ON 12-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOT NUMBER OF THE DETACHMENT HANDLE IS UNKNOWN. WHEN THE 3MM X 8CM CEREPAK FREEFORM XSFT WAS REMOVED FROM THE PATIENT, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM, AND IT WAS NOT STRETCHED. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE REPLACEMENT WAS ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926230 ↗
• MalfunctionSep 3, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, CEREPAK COILS WERE BEING USED TO EMBOLIZE A VENUS FISTULA FEEDER. USING A CEREBASE GUIDE SHEATH, VECTA 46 CATHETER AND A SCEPTER XC BALLOON CATHETER TO INSERT COILS. WHEN USING THE MECHANICAL DETACHMENT HANDLE FOR A FREEFORM XSFT 3MM X 8 CM COIL (XCR120308, 31112709), THE HANDLE WAS MOVED TOO FAR LATERALLY/TOWARDS THE PHYSICIAN WHICH CAUSED THE MANUAL BREAK POINT AND PULL WIRE TO FRACTURE. THE PHYSICIAN BELIEVED IT WAS USER ERROR FOR MOVING THE PUSHER TUB/HANDLE. THE COIL WAS THEN REMOVED. NO DELAY OR PATIENT HARM OCCURRED. A FREEFORM XSFT 4MM X 8 CM COIL (XCR120408, LOT UNKNOWN) WAS PLACED BUT FAILED TO DETACH WITH MANUAL BREAK. THE MANUAL BREAK WAS INITIATED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER INITIAL BREAK AND PULL, THE COIL DIDN¿T DETACH. THE PHYSICIAN THEN PULLED A SECOND TIME, PULLING MANY CM OF WIRE. THE COIL STILL DIDN¿T DETACH. THE COIL WAS THEN REMOVED. NO PATIENT HARM OCCURRED AND NO SIGNIFICANT DELAYED OCCURRED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-AUG-2024 INDICATING THAT THE FREEFORM XSFT 3MM X 8 CM WAS THE FIRST COIL USED. WHEN THE FREEFORM XSFT 4MM X 8 CM COIL WAS USED, THERE HAD BEEN 7

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125913 ↗
• MalfunctionJul 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE PROXIMAL ANATOMY WAS TORTUOUS IN CAROTID ARTERY. AN INTERMEDIATE VECTA 071 CATHETER WAS USED, TWO SL 10 MICROCATHETERS WERE PLACED AND AN ATLAS STENT PLACEMENT. THE FIRST COIL, A FREEFORM XSFT WAS DEPLOYED AND DETACHED USING THE DETACHER WITHOUT DIFFICULTY. A SECOND COIL, A FREEFORM XSFT 3.5MM X 9 CM (XCR123509, 31173120) AND A THIRD COIL, A FREEFORM XSFT 3MM X 8 CM (XCR120308, 31112709) WERE DEPLOYED BUT DID NOT DETACH. EACH USING MECHANICAL DETACHMENT HANDLER (MDH1 , LOT UNKNOWN) FIRST AND MANUAL BREAK SECOND. THE PHYSICIAN COMPLETED THE CASE USING 8 MORE STRYKER COILS ALL DETACHING WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800030 ↗
• MalfunctionMar 6, 2024Break; Break

  ON 26-FEB-2024, VIA THE MEDSUN REPORT 4400150000-2024-8008, THERE WERE THREE ADDITIONAL COILS DOCUMENTED. THE COILS ARE A 2MM X 4CM CEREPAK FREEFORM MINI (MCR092040 / 31098100), A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31136064), AND A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / 31162597). ON 04-MAR-2024, CLARIFYING INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE. THE INFORMATION INDICATED THAT THE 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31136064) WAS OPENED AND THE TECH BENT THE COIL WHILE ADVANCING IT THROUGH THE MICROCATHETER; THE COIL WAS REMOVED AND DISCARDED. THE 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / 31162597) WAS ALSO BENT BY THE TECH DURING ADVANCEMENT THROUGH THE MICROCATHETER; IT WAS ALSO REMOVED AND DISCARDED. THE 2MM X 4CM CEREPAK FREEFORM MINI (MCR092040 / 31098100) WAS OPENED AND AN ATTEMPT WAS MADE TO PLACE THE COIL, BUT THE ANEURYSM WOULD NOT ACCOMMODATE THE COIL SO IT WAS REMOVED AND THE PHYSICIAN ENDED THE PROCEDURE. THERE WAS NO ISSUE ASSOCIATED WITH THIS COIL. IT WAS ALSO DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852971 ↗
• MalfunctionFeb 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE BASILAR ARTERY ANEURYSM, AFTER SUCCESSFULLY PLACING ONE COIL, FOUR (4) ADDITIONAL COILS WERE USED WITH FAILED DETACHMENTS USING THE MANUAL BREAK. THE FOUR (4) COILS THAT HAD FAILED DETACHMENT ATTEMPTS WERE: A 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / (B)(6)), A 4MM X 6CM CEREPAK FREEFORM XSFT (XCR120406 / (B)(6)), A 4MM X 8CM CEREPAK FREEFORM XTRASOFT (XCR120408 / (B)(6)), AND A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / (B)(6)). THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED TO CONTINUE WITH THE DETACHER HANDLE AND SUCCESSFULLY DETACHED TEN (10) MORE COILS. THE PHYSICIAN USED A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH FLUSH LINES. IT WAS REPORTED THAT THE SYSTEM WAS STRAIGHTENED WITH NO BENDS PRIOR TO DETACHMENTS. THE SL-10® MICROCATHETER WAS USED THROUGH THE ENTIRE PROCEDURE TO ITS SUCCESSFUL CONCLUSION. THERE WAS NO PROCEDURE DELAY REPORTED AS A RESULT OF THE FAILED DETACHMENT ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681832 ↗
• MalfunctionJan 2, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A FISTULA EMBOLIZING WITH MODERATE TORTUOSITY, THE USER DEPLOYED A TOTAL OF 13 COILS. THE FOLLOWING THREE COILS DID NOT DETACH UTILIZING THE MANUAL DETACHMENT: FREEFORM 5MM X 10 CM (SCR120510, 31090185), FREEFORM XSFT 3MM X 8 CM (XCR120308, 31162597) AND FREEFORM XSFT 4MM X 6 CM (XCR120406, 31140708). BREAKING OF THE MANUAL BREAK WAS DIFFICULT. BUT WAS ULTIMATELY ABLE TO EXPOSE THE PULL WIRE AND PULL BACK THE WIRE TO ATTEMPT TO DETACH COIL. THIS DIFFICULTY WITH THE BREAKING OF THE MANUAL BREAK AT THE SCORING HAPPENED ON ALL OF THE COILS REGARDING THIS COMPLAINT. ALL THREE COILS WERE ABLE TO BE REMOVED WITHOUT PATIENT INCIDENT, ONE OF THE COILS DETACHED ON THE TABLE AFTER REMOVAL. MINIMAL DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430938 ↗