CEREPAK FREEFORM XCR120410Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704083689), received between Aug 26, 2024 and Sep 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN WAS USING A FREEFORM XSFT 4MM X 10 CM COIL (XCR120410, 31112708). HE REPORTED THAT WHEN INSERTING THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) ONTO THE PUSHER WIRE OF THE COIL IT GOT STUCK AND IT WOULD NOT DETACH. HE REMOVED THE COIL AND DETACHER AND USED A NEW 4X10 COIL WITH A NEW DETACHER AND OTHER COILS WITHOUT ANY ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062907 ↗
• MalfunctionMay 2, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953946 ↗
• MalfunctionMay 2, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953821 ↗
• MalfunctionMar 27, 2025Break; Break

  AS REPORTED BY THE FIELD, A FREEFORM XSFT 4MM X 10 CM COIL (XCR120410, 31107820) AND A FREEFORM 10MM X 30 CM COIL (SCR121030, 31177734) WERE ¿DEFECTIVE". ADDITIONAL EVENT INFORMATION RECEIVED ON 13-FEB-2025 INDICATED THAT THE COIL EMBOLIZATION WAS TO A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (BIFURCATION). THERE WAS NO DELAY IN CARE. A 6FR ENVOY DA 95CM, LPES 45, AGILITY SOFT, SHORT SHEATH WERE USED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF BOTH DEVICES RECEIVED, THE EMBOLIC COIL FAILED TO DETACH, WAS FOUND KINK/BENT AND UNRAVELED/STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708247 ↗
• MalfunctionFeb 13, 2025Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410) FROM THE SAME LOT NUMBER (31218776) DID NOT DETACH WITH THE DETACHMENT HANDLE (MDH1 / 102109430) OR VIA MANUAL BREAK. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 05-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE PROCEDURE WAS A VESSEL SACRIFICE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY. THE VESSEL MEASURED 3.5MM. BOTH COILS WERE CONFIRMED TO BE FROM THE SAME LOT (31218776). THE LOT NUMBER OF THE DETACHMENT HANDLE IS 102109430. THE SAME HANDLE WAS USED WITH BOTH COILS, AND IT IS NOT AVAILABLE FOR RETURN. WHEN THE COILS WERE REMOVED, THEY WERE NOT STRETCHED; BOTH COILS WERE DETACHED, ONE HAD THE DETACHMENT WIRE STILL ON IT. THE CONCOMITANT MICROCATHETER WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COIL. THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376557 ↗
• MalfunctionFeb 13, 2025Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410) FROM THE SAME LOT NUMBER: (31218776) DID NOT DETACH WITH THE DETACHMENT HANDLE (MDH1 / 102109430) OR VIA MANUAL BREAK. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 05-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE PROCEDURE WAS A VESSEL SACRIFICE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY. THE VESSEL MEASURED 3.5MM. BOTH COILS WERE CONFIRMED TO BE FROM THE SAME LOT: (31218776). THE LOT NUMBER OF THE DETACHMENT HANDLE IS 102109430. THE SAME HANDLE WAS USED WITH BOTH COILS, AND IT IS NOT AVAILABLE FOR RETURN. WHEN THE COILS WERE REMOVED, THEY WERE NOT STRETCHED; BOTH COILS WERE DETACHED, ONE HAD THE DETACHMENT WIRE STILL ON IT. THE CONCOMITANT MICROCATHETER WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COIL. THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376556 ↗
• MalfunctionAug 26, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED ANEURYSM LOCATED ON THE LEFT MIDDLE CEREBRAL ARTERY (MCA), COILS WERE PLACED THROUGH THE HEADWAY® DUO 156 MICROCATHETER (MICROVENTION). EACH PRODUCT USED DURING THE PROCEDURE WAS IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE FIRST COIL WAS A 5MM X 17CM CEREPAK UNIFORM COIL BUT IT WAS TOO SMALL. THE SECOND COIL WAS A 7MM X 30CM CEREPAK UNIFORM BUT THE COIL WAS TOO LARGE; THERE WERE NO REPORTED ISSUES WITH THESE FIRST TWO COILS. THE THIRD COIL WAS A 6MM X 26CM CEREPAK UNIFORM (FCX100626 / 31177724). THE DETACHMENT HANDLE (MDH1 / 102109430) WAS USED, BUT THE COIL FAILED TO DETACH AFTER THE FIRST ATTEMPT. MANUAL BREAK WAS SUCCESSFULLY ATTEMPTED. THE FOURTH COIL WAS A 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31136148). THIS COIL FAILED TO DETACH AFTER THE FIRST ATTEMPT USING THE HANDLE. MANUAL BREAK ATTEMPT WAS ALSO UNSUCCESSFUL AND THE PULL WIRE SHEARED OFF. THE FOURTH, FAILED TO DETACH COIL WAS REMOVED FROM THE PATIENT. THE FIFTH COIL WAS A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31162595). ATTEMPT TO DETACH THE FIFTH COIL VIA THE HANDLE WAS NOT SUCCESSFUL. MANUAL BRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070179 ↗