CEREPAK FREEFORM SCR120407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704083115), received between Jul 9, 2024 and Feb 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Separation Failure; Material Twisted/Bent; Difficult or Delayed Separation; Separation Failure; Material Twisted/Bent; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TWO (2) COILS, A 4MM X 7CM CEREPAK FREEFORM (SCR120407 / 31149189) AND A 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530 / 31136144) FAILED TO DETACH. ONE COIL DELIVERY WIRE WAS BADLY BENT UPON REMOVAL. ONLY ONE COIL WAS USED WITH THE DETACHMENT HANDLE (MDH1 / 102109430). NO ALTERNATIVE WAS ATTEMPTED (I.E., MANUAL DETACHMENT). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE COIL DELIVERY WIRE OF THE 4MM X 7CM CEREPAK FREEFORM (SCR120407) WAS BADLY BENT ON EXPLANT. THE DETACHMENT HANDLE (MDH1) WAS USED WITH BOTH COILS; ON THE 4MM X 7CM CEREPAK FREEFORM (SCR120407), THE DETACHMENT HANDLE WAS USED AS WELL AS THE MANUAL BREAK. ON THE 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530), THE DETACHMENT HANDLE WAS USED ONCE AND THEN THE COIL WAS EXPLANTED; MANUAL DETACHMENT ATTEMPT WAS NOT MADE WITH THE 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530). THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 102109430. THE DETACHMENT HANDLE IS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21350308 ↗
• MalfunctionJan 30, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM), A FREEFORM 4MM X 7 CM COIL (SCR120407, 31149189) WAS ADVANCED AND ATTEMPTED TO BE DETACHED 3 TIMES WITH A MECHANICAL DETACHMENT HANDLE (MDH1, UNKNOWN LOT), THE COIL WOULD NOT DETACH AND IT WAS REMOVED. THE COIL WAS NOT BENT OR DAMAGED VISIBLE INSPECTION BY PHYSICIAN. TWO STRYKER XL COILS (4X8 AND 3X6) WERE USED TO FINISH CASE. PRIOR TO THIS COIL, THE FOLLOWING CEREPAK COILS WERE ADVANCED AND DETACHED WITH A WITH MECHANICAL DETACHER HANDLE WITHOUT A PROBLEM (7X15 ,6X10,6X10,5X10,4X7). THERE WAS NO PATIENT INJURY REPORTED. BENCHMARK GUIDE CATHETER RICA , SL-10 MICROCATHETER WITH SYNCHRO 2 SOFT 14 GUIDEWIRE WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274978 ↗
• MalfunctionAug 27, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO DETACH A UNIFORM 4MM X 7.5 CM COIL (FCX100407, 31154117) AND A FREEFORM 4MM X 7 CM COIL (SCR120407, 31149189), HOWEVER, BOTH COILS WOULD NOT DETACH. HE WAS ABLE TO GAIN ACCESS TO THE ANEURYSM PROPERLY AND DEPLOY THE CEREPAK COILS. ONCE THE COIL WAS IN PLACE PROPERLY, HE ATTEMPTED TO DETACH THE COIL USING A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND NOTHING HAPPENED. HE THEN ATTEMPTED TO MANUALLY BREAK. HE DID A TEXT BOOK MANUAL BREAK AND THE COIL DID NOT DETACH. HE THEN HAD TO REMOVE THE COIL. THE SECOND ATTEMPT WITH THE SECOND COIL WENT EXACTLY THE SAME. HE FIRST ATTEMPTED TO USE THE DETACHER. IT DID NOT DETACH SO HE THEN ATTEMPTED TO MANUALLY BREAK. IT DID NOT BREAK. THE COILS WERE REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076006 ↗
• MalfunctionJul 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO COILS ¿ A 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31140705) AND A 4MM X 7CM CEREPAK FREEFORM (SCR120407 / 31149189) WOULD NOT DETACH ONCE DEPLOYED IN A CEREBRAL ANEURYSM. THE COILS WERE SUCCESSFULLY REMOVED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITH THE PATIENT SUCCESSFULLY TREATED WITH DIFFERENT COILS. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUES. ON 09-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE TARGET ANEURYSM WAS THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE ATTEMPTS TO DETACH THE COILS WERE MADE USING THE DETACHMENT HANDLE AS WELL AS MECHANICAL BREAK. THE CATALOG AND LOT NUMBER OF THE DETACHMENT HANDLE USED WAS MDH1 / 102109430. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED. BOTH COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED. THE MICROCATHETER USED WAS A PROWLER SELECT LPES (MC1755S2U / 30967330). THE INFORMATION INDICATED THAT THE COILS WERE NOT REPLACED WITH COILS FROM THE SAME PRODUCT CODES OR DIFFERENT BRANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707391 ↗