CEREPAK FREEFORM MCR092030Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704082996), received between Dec 18, 2023 and Jul 21, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Separation Failure; Separation Failure

  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 22556389 ↗
• MalfunctionMar 12, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TO THE INTERNAL CAROTID ARTERY (ICA), A UNIFORM 5MM X 9.7 CM COIL (FCX100509, 31218796), A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31349399) AND A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31077163) DID NOT DETACHED WITH MANUAL BREAK METHOD. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 INDICATED THAT A PROWLER LPES MICROCATHETER WAS USED. SEVEN COILS WERE PREVIOUSLY PLANTED WITH NO ISSUES. THERE HAD BEEN NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE(S) THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO ATTEMPTS MADE USING THE DETACHMENT HANDLE. THERE WAS NO COIL DAMAGE. THIS WAS A TORTUOUS VESSEL WITH WIDE NECK DEFECT. THE THREE MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT. ALL THREE COILS HAD TO BE RESHEATHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585260 ↗
• MalfunctionMar 12, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TO THE INTERNAL CAROTID ARTERY (ICA), A UNIFORM 5MM X 9.7 CM COIL (FCX100509, 31218796), A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31349399) AND A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31077163) DID NOT DETACHED WITH MANUAL BREAK METHOD . ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 INDICATED THAT A PROWLER LPES MICROCATHETER WAS USED. SEVEN COILS WERE PREVIOUSLY PLANTED WITH NO ISSUES. THERE HAD BEEN NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE(S) THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO ATTEMPTS MADE USING THE DETACHMENT HANDLE. THERE WAS NO COIL DAMAGE. THIS WAS A TORTUOUS VESSEL WITH WIDE NECK DEFECT. THE THREE MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT. ALL THREE COILS HAD TO BE RESHEATHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585232 ↗
• MalfunctionFeb 13, 2025Separation Failure; Separation Failure

  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 21375674 ↗
• MalfunctionMay 23, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31092856) WAS PLACED IN AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. MANUAL DETACHMENT WAS ATTEMPTED ACCORDING TO THE INSTRUCTIONS FIR USE (IFU) BUT FAILED TO DETACH. TWO ATTEMPTS TO RETRACT THE PULL WIRE WERE UNSUCCESSFUL AND THE COIL WAS REMOVED FROM THE PATIENT. A STRYKER COIL WAS THEN PLACED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE MICROCATHETER WAS AN SL10. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-MAY-2024 INDICATED THAT ONE COIL HAD BEEN PREVIOUSLY IMPLANTED IN A DIFFERENT ANEURYSM. 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 COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOTED AS HAVING MODERATE CAROTID TORTUOSITY. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15 MINUTES AND THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381627 ↗
• MalfunctionMay 6, 2024Separation Failure; Difficult to Advance; Premature Separation; Separation Failure; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31077163) WAS DEFECTIVE. RESISTANCE WAS FELT UPON ADVANCING THE COILING INTO THE BODY. ONCE THE COIL WAS ADVANCED INTO THE ANEURYSM, DETACHMENT ERROR OCCURRED, NO DETACHMENT. UPON REMOVING THE COIL FROM THE ANEURYSM, THE COIL DETACHED INSIDE THE SL-10 MICROCATHETER (MC). MICROCATHETER AND COIL WERE REMOVED FROM THE PATIENT AND SAVED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-MAY-2024 INDICATED THAT ONE CEREPAK COIL WAS IMPLANTED, THE REST WERE PENUMBRA COILS AFTER THIS COIL FAILED TO DETACH PROPERLY. THERE WAS NO POSITIONING DIFFICULTY IN THE ANEURYSM. NO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE, ONLY MANUAL BREAK DETACHMENT. NO DAMAGES WERE NOTED ON THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE EVENT DID NOT RESULT IN PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248979 ↗
• MalfunctionDec 28, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING A BASILAR TIP ANEURYSM, THE PHYSICIAN HAD THE MICROCATHETER JAILED IN THE ANEURYSM. AFTER INSERTION OF THE 7TH COIL, A 2MM X 3CM CEREPAK FREEFORM MINI (MCR092030 / 31077163), THE PHYSICIAN ATTEMPTED TO DETACH THE COIL BY MANUAL BREAK AND THE COIL DID NOT DETACH. THE PHYSICIAN ONLY MADE ONE ATTEMPT AND IMMEDIATELY REMOVED THE COIL SYSTEM FROM THE MICROCATHETER WITH THE COIL INTACT AND WITHOUT EVENT. THE TECH SET THE COIL ON THE BACK TABLE AND THE PHYSICIAN FINISHED COILING THE ANEURYSM AND COMPLETED THE CASE WITHOUT EVENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 11-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE MICROCATHETER USED WAS AN SL-10® MICROCATHETER (STRYKER). THE PREVIOUS SIX COILS USED CONSISTED OF ONE (1) CEREPAK UNIFORM AND FIVE (5) FREEFORM. THE 7TH COIL WAS REPLACED WITH ANOTHER CEREPAK FREEFORM OF A DIFFERENT SIZE; IT WAS USED WITH THE SAME SL-10® MICROCATHETER. THE INFORMATION INDICATED THAT WHEN THE COIL WAS REMOVED, IT WAS NOT STRETCHED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410428 ↗
• MalfunctionDec 18, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE, THE PHYSICIAN PLACED TWO CEREPAK COILS; THE COILS WERE DEPLOYED IN THE RIGHT DISTAL MMA DUE TO OPHTHALMIC BLUSH. THE FIRST COIL WAS A 1MM X 3CM CEREPAK FREEFORM MINI (MCR091030 / 31140702), THE SECOND COIL WAS A 2MM X 8CM CEREPAK HELIFORM XSFT XL (XHE120208 / 31162599). THE PHYSICIAN ATTEMPTED TO PLACE A THIRD COIL, A 2MM X 3CM CEREPAK FREEFORM MINI (MCR092030 / 31077163). IT WAS REPORTED THAT THIS THIRD COIL DID NOT DETACH. INSERTION OF THE COIL WENT SMOOTHLY. THE CLINICAL REPRESENTATIVE REPORTEDLY ¿STEPPED BEHIND THE TABLE TO BE [THE PHYSICIAN¿S] LOOK OUT FOR INVERTED T.¿ IT WAS REPORTED THAT AS THE CLINICAL REPRESENTATIVE ¿CALLED OUT INVERTED T AND WENT TO WALK TO THE END OF THE PROCEDURE TABLE TO WATCH DETACHMENT, I SAW [THE PHYSICIAN] PULLING. HE PULLED MORE THAN A FEW CM, MORE THAN 6M AS HE FLUORO¿ED TO VERIFY DETACHMENT, HE ASKED DID IT NOT DETACH? IT WAS HARD TO VISUALIZE UNDER FLUORO. HE PULLED OUT THE COIL SYSTEM AND THE COIL WAS STILL ATTACHED TO THE SYSTEM.¿ THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351924 ↗