CEREPAK FREEFORM MCR093060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704083061), received between Mar 6, 2024 and Nov 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, EIGHT (8) COILS WERE IMPLANTED WITHOUT FAIL. TWO COILS FAILED TO DETACH: THE TWO COILS ARE A 12MM X 30CM CEREPAK FREEFORM (SCR121230 / 31173118) AND A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31207074). IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 30-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM WAS AN UNRUPTURED SACCULAR ANEURYSM WITH A SIZE OF 11MM. THE DETACHMENT HANDLE (MDH1 / 102109430) WAS USED ON THE FIRST COIL, THE 12MM X 30CM CEREPAK FREEFORM (SCR121230 / 31173118) FOR ONE DETACHMENT ATTEMPT, WHEN THE COIL DID NOT DETACH, THEY SWITCHED TO MANUAL BREAK. THE 12MM X 30CM CEREPAK FREEFORM COIL STILL DID NOT DETACH. PER THE INFORMATION, MANUAL BREAK WAS THE PRIMARY METHOD OF DETACHMENT FOR ALL REMAINING COILS. THE DETACHMENT HANDLE IS NOT AVAILABLE FOR RETURN. WHEN THE 12MM X 30CM CEREPAK FREEFORM COIL WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. WHEN THE 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 /

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700413 ↗
• MalfunctionSep 18, 2024Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A FREEFORM MINI 3MM X 6CM COIL, (MCR093060, 31349400) STRETCHED ONCE INSERTED INTO THE RHV HUB OF THE MICROCATHETER AND ULTIMATELY SOMEHOW DETACHED WITHIN THE MICROCATHETER. HOWEVER, THE PHYSICIAN AND THE LEAD TECH, NOTICED RIGHT AWAY AND THE ENTIRE MICROCATHETER WAS REMOVED FROM THE PATIENT WITH THE DETACHED COIL INSIDE AND ANEW MICROCATHETER WAS USED. THERE WAS A 10-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-SEP-2024 INDICATED THAT PREVIOUS COILS WERE ABLE TO BE ADVANCED THRU THE SAME MICROCATHETER BEFORE THE ISSUE. THE PHYSICIAN HAD TO ACCESS THE ANEURYSM WITH A BRAND NEW MICROCATHETER AND GUIDEWIRE. THE WAS NO CLINICAL SIGNIFICANCE IN THE 10 MINUTE PROCEDURAL DELAY, HOWEVER, THERE WAS ADDED RISK HAVING TO RE-ACCESS DUE TO OUR COIL PREMATURELY DETACHING IN THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247681 ↗
• MalfunctionMar 25, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, THE PHYSICIAN WAS EMPLOYING THE STENT/COIL TECHNIQUE. A STENTING MICROCATHETER (UNSPECIFIED BRAN) WAS PLACED DISTAL TO THE ANEURYSM. A COIL MICROCATHETER, EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) WAS PLACED INTO THE ANEURYSM. THE STENT WAS SUCCESSFULLY DEPLOYED JAILING THE XT-17 MICROCATHETER. A 4MM X 10CM CEREPAK FREEFORM XTRASOFT COIL WAS PLACED INTO THE ANEURYSM AND DETACHED SUCCESSFULLY VIA A DETACHMENT HANDLE. A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31162595) WAS INTRODUCED INTO THE ANEURYSM AND AFTER PROPER ALIGNMENT OF THE DETACHMENT MARKERS WERE NOTED, A HANDLE DETACHMENT WAS PERFORMED. VISUALIZATION OF THE PROXIMAL PULL WIRE WAS NOTED TO HAVE APPROXIMATELY DOUBLED IN LENGTH AFTER THE DETACHMENT ATTEMPT. IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE COIL WAS NOT DETACHED. A SECOND HANDLE (MDH1 / LOT# UNKNOWN) WAS PERFORMED WITH SIMILAR RESULTS. THE PHYSICIAN THEN PERFORMED MANUAL BREAK DETACHMENT WHICH ALSO DID NOT DETACH THE COIL. THE COIL WAS EFFECTIVELY REMOVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976016 ↗
• MalfunctionMar 11, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 81-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION TARGETING A BASILAR ANEURYSM. THE PHYSICIAN DECIDED TO USE CEREPAK COILS TO TREAT THE ANEURYSM; THIS WAS HIS FIRST TIME USING CEREPAK FOR A PATIENT. A STENTING MICROCATHETER WAS PLACED DISTAL TO THE ANEURYSM. A PHENOM¿ 17 MICROCATHETER (MEDTRONIC) WAS PLACED INTO THE ANEURYSM. A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31162595) WAS INTRODUCED INTO THE ANEURYSM WITH A SINGLE LOOP PLACED INTO THE ANEURYSM FOR APPROXIMATELY 3 MINUTES WHILE THE STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM, JAILING THE COIL CATHETER WITHIN THE ANEURYSM. THE REMAINING COIL WAS THEN INTRODUCED INTO THE ANEURYSM WITH THE PROPER DETACHMENT MARKERS ALIGNED FOR COIL DETACHMENT. THE MANUAL BREAK TECHNIQUE WAS PERFORMED BY THE PHYSICIAN¿S FELLOW PHYSICIAN. AT THIS TIME, FLUOROSCOPY WAS USED TO CONFIRM COIL DETACHMENT, WHICH WAS REPORTEDLY NOT ACHIEVED. THE PHYSICIAN WAS THEN INSTRUCTED TO GENTLY PULL THE REMAINING PULL WIRE BECAUSE THE PROXIMAL HYPOTUBE WAS PULLED OFF DURING THE FIRST DETACHMENT ATTEMPT. FAILURE OF DETACHMENT WAS CONFIRMED VIA FLUOROSCOPY, WHICH AT THAT POINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882539 ↗
• MalfunctionMar 6, 2024Break; Break

  ON 26-FEB-2024, VIA THE MEDSUN REPORT (B)(4), 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 18852968 ↗