CEREPAK FREEFORM MCR091020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704082910), received between Jul 10, 2023 and Nov 3, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (11 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, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON 03-SEP-2025, AS EACH COIL LISTED: A 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020 / 31345668), A 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525 / 31216617), 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020 / 31258390), AND 1MM X 3CM CEREPAK FREEFORM MINI (MCR091030 / 31585342) WAS BEING ADVANCED INTO THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC), THE PHYSICIAN ENCOUNTERED RESISTANCE AS THE COIL ENTERED THE MICROCATHETER. THE PHYSICIAN RE-SHEATHED THE COIL, CHECKED TO ENSURE THE INTRODUCER WAS ¿HUBBED¿ CORRECTLY WITHIN THE MICROCATHETER, CONFIRMED THE SYSTEM WAS BEING FLUSHED AND TRIED ADVANCE THE COIL AGAIN. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE MORE THAN APPROXIMATELY 5 CM INTO THE MICROCATHETER. EACH COIL WAS PLACED ON THE BACK TABLE FOR INVESTIGATION FOLLOWING THE CASE. THE TWO COILS THAT WERE AVAILABLE FOR RETURN: 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020) AND 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525) WOULD NOT ADVANCE OUTSIDE OF THE INTRODUCER. NONE OF THE COILS WERE INTRODUCED INTO THE PATIENT¿S BODY. THE INABILITY OF THE COILS TO BE ADVANCED THROUGH THE MICROCATHETER DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444638 ↗
• MalfunctionAug 11, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A TUMOR EMBOLIZATION, A FREEFORM MINI 1MM X 2CM COIL (MCR091020, 31337120) 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 22771607 ↗
• MalfunctionJul 15, 2025Separation Failure; Separation Failure

  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 22508982 ↗
• MalfunctionJul 8, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO A POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. THE FIRST 4 COILS WERE DEPLOYED WITHOUT AN ISSUE. THE 5TH COIL, A FREEFORM MINI 1MM X 3CM ( MCR091030, 31140702) WAS SITUATED AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLER (MDH1, 102109430) WHICH DID NOT DETACH. MANUAL BREAK METHOD WAS THEN ATTEMPTED, ONCE AGAIN FAILING TO DETACH AT BOTH 2CM PULL AND 4CM PULL. COIL WAS REMOVED AND A 6TH COIL, A FREEFORM MINI 1MM X 2CM (MCR091020, 31131257) WAS POSITIONED. AFTER ATTEMPTING AND FAILING DETACHMENT WITH HANDLE MANUAL BREAK METHOD WAS UTILIZED AGAIN. THE COIL STILL FAILED TO DETACH AND WAS THEREFORE REMOVED. CASE WAS COMPLETED WITH ONE COMPETITIVE COIL. THERE WAS A 10-MINUTE PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 24-JUN-2024 INDICATING THAT A PHENOM 17 150CM MICROCATHETER WAS USED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICES THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS MODERATELY TORTUOUS, NOTHING ¿EXTREME¿ PER T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689397 ↗
• MalfunctionJan 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, TWO FREEFORM MINI 1MM X 2CM COILS (MCR091020, 31131257) DID NOT DETACH. THE INNER PULL WIRE WAS NOT PRESENT ON THE TWO COILS. MANUAL BREAK WAS PERFORMED NO PULL WIRE WAS VISIBLE ON BOTH COILS WHEN DETAILING. PROXIMAL PORTION OF MANUAL BREAK SEPARATED 100% FROM DELIVERY SYSTEM. COILS WERE REMOVED INTACT AND STILL ON DELIVERY SYSTEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552036 ↗
• MalfunctionJan 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, TWO FREEFORM MINI 1MM X 2CM COILS (MCR091020, 31131257) DID NOT DETACH. THE INNER PULL WIRE WAS NOT PRESENT ON THE TWO COILS. MANUAL BREAK WAS PERFORMED NO PULL WIRE WAS VISIBLE ON BOTH COILS WHEN DETAILING. PROXIMAL PORTION OF MANUAL BREAK SEPARATED 100% FROM DELIVERY SYSTEM. COILS WERE REMOVED INTACT AND STILL ON DELIVERY SYSTEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552005 ↗
• MalfunctionNov 13, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) 1MM X 2CM CEREPAK FREEFORM MINI COILS (MCR091020) FROM THE SAME LOT (31131257) DID NOT DETACH. MULTIPLE ATTEMPTS WERE TRIED WITH THE CEREPAK DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123447 ↗
• MalfunctionNov 13, 2023Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) 1MM X 2CM CEREPAK FREEFORM MINI COILS (MCR091020) FROM THE SAME LOT (31131257) DID NOT DETACH. MULTIPLE ATTEMPTS WERE TRIED WITH THE CEREPAK DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123265 ↗
• MalfunctionNov 9, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), A FREEFORM MINI 1MM X 2CM COIL (MCR091020, 31131257) DID NOT DETACH. THE USER TRIED TO DETACH THE COIL WITH A MECHANICAL DETACHMENT HANDLE (MDH1, 101456956) AND TRIED DETACHING USING THE MANUAL BREAK. A SECOND MECHANICAL DETACHMENT HANDLE (PRODUCT/LOT UNKNOWN) WAS USED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 INDICATED THAT A SL10 MICROCATHETER WAS USED FOR COILING. FOUR CEREPAK COILS WERE PREVIOUSLY IMPLANTED. THERE WAS NO RESISTANCE IN DELIVERY THROUGH MICROCATHETER (MC). DELIVERY WAS SMOOTH WITH NO FRICTION. TWO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE COIL, NO KINKS, OR BENDS IN DELIVERY. NO EXCESSIVE TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103131 ↗
• MalfunctionOct 10, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE LEFT MIDDLE MENINGEAL ARTERY(MMA) WAS ACCESSED WITH A STRYKER SL-10 MICROCATHETER. A FREEFORM MINI 1MM X 2CM WAS SUCCESSFULLY DELIVERED AND DETACHED. NEXT A FREEFORM MINI 1MM X 2CM (MCR091020, 31092858) WAS DELIVERED BUT WOULD NOT DETACH AFTER TWO ATTEMPTS WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, 101456956). THE COIL AND DELIVERY SYSTEM WERE SUCCESSFULLY REMOVED FROM THE PATIENT VIA THE SL-10 CATHETER. THIS COIL AND DELIVERY SYSTEM WAS SAVED BY THE ACCOUNT AND WILL BE RETURNED AS PART OF THE COMPLAINT. A SECOND FREEFORM MINI 1MM X 2CM (MCR091020, 3109258)) WAS DELIVERED BUT WOULD NOT DEPLOY AFTER TWO ATTEMPTS WITH THE MECHANICAL DETACHMENT HANDLE (MDH1) AND USING THE MANUAL BREAK DEPLOYMENT TECHNIQUE. WHILE ATTEMPTING TO REMOVE THE COIL AND DELIVERY SYSTEM THROUGH THE SL-10 CATHETER, THE COIL DETACHED WITH HALF OF THE COIL IN THE ARTERY AND THE OTHER HALF IN THE CATHETER. THE PHYSICIAN THEN TOOK THE DELIVERY WIRE OF A STRYKER TARGET COIL, PUSHED IT THROUGH THE SL-10 AND PUSHED THE REMAINING MCR091020 OUT THE CATHETER AND INTO THE VESSEL. FROM THERE, THE PHYSICIAN CONTINUED THE EMBOLIZATION WITH COMPETITIVE COILS SUCCESSF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905857 ↗
• MalfunctionOct 10, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE LEFT MIDDLE MENINGEAL ARTERY(MMA) WAS ACCESSED WITH A STRYKER SL-10 MICROCATHETER. A FREEFORM MINI 1MM X 2CM WAS SUCCESSFULLY DELIVERED AND DETACHED. NEXT A FREEFORM MINI 1MM X 2CM (MCR091020, 31092858) WAS DELIVERED BUT WOULD NOT DETACH AFTER TWO ATTEMPTS WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, 101456956). THE COIL AND DELIVERY SYSTEM WERE SUCCESSFULLY REMOVED FROM THE PATIENT VIA THE SL-10 CATHETER. THIS COIL AND DELIVERY SYSTEM WAS SAVED BY THE ACCOUNT AND WILL BE RETURNED AS PART OF THE COMPLAINT. A SECOND FREEFORM MINI 1MM X 2CM (MCR091020, 3109258) WAS DELIVERED BUT WOULD NOT DEPLOY AFTER TWO ATTEMPTS WITH THE MECHANICAL DETACHMENT HANDLE (MDH1) AND USING THE MANUAL BREAK DEPLOYMENT TECHNIQUE. WHILE ATTEMPTING TO REMOVE THE COIL AND DELIVERY SYSTEM THROUGH THE SL-10 CATHETER, THE COIL DETACHED WITH HALF OF THE COIL IN THE ARTERY AND THE OTHER HALF IN THE CATHETER. THE PHYSICIAN THEN TOOK THE DELIVERY WIRE OF A STRYKER TARGET COIL, PUSHED IT THROUGH THE SL-10 AND PUSHED THE REMAINING MCR091020 OUT THE CATHETER AND INTO THE VESSEL. FROM THERE, THE PHYSICIAN CONTINUED THE EMBOLIZATION WITH COMPETITIVE COILS SUCCESSFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905855 ↗
• MalfunctionJul 10, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THE PHYSICIAN USED A FREEFORM MINI 1MM X 2CM COIL (MCR091020, 30982991) FOR A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. HOWEVER, THE COIL DID NOT DETACH. THE PHYSICIAN FIRST TRIED DETACHING USING THE DETACHMENT HANDLE AND THEN DID A MANUAL BREAK USING THE CORRECT METHOD, BUT IT STILL DID NOT DETACH. HE THEN PULLED THE COIL OUT OF THE PATIENT. COIL WAS USED WITH A STRYKER SL10 MICROCATHETER. THERE WAS NO SURGERY DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287409 ↗