CEREPAK HELIFORM XHE120208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704083955), received between Dec 5, 2023 and May 2, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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.

• 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 21953822 ↗
• MalfunctionNov 5, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL THAT AFTER EMBOLIZATION OF THE RIGHT MIDDLE MENINGEAL ARTERY (MMA) WITH TRUFILL N-BCA (CATALOG / LOT# UNKNOWN), A POST-EMBOLIZATION RUN WAS PERFORMED AND EXTRAVASATION WAS OBSERVED. A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208) WAS USED TO EMBOLIZE THE TRUNK OF THE RIGHT MMA ¿ AT THE SITE OF THE VESSEL RUPTURE. THE FIRST 2MM X 8CM CEREPAK HELIFORM XSFT DETACHED FLAWLESSLY. A SECOND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168) WAS USED BUT IT FAILED TO DETACH AFTER TWO DETACHMENT ATTEMPTS WITH THE DETACHMENT HANDLE (MDH1 / 97988374). THE PHYSICIAN WAS INSTRUCTED TO USE MANUAL BREAK AND THE COIL STILL FAILED TO DETACH AFTER TWO SEPARATE PULLS OF THE PULL WIRE. THE COIL WAS THEN RECAPTURED. IT WAS REPORTED THAT THE SYSTEM WAS STRAIGHT DURING THE CASE AND DURING THE DETACHMENT. VESSEL TORTUOSITY WAS MILD TO MODERATE BUT MAINLY SEEN AT THE RIGHT EXTERNAL CAROTID ARTERY (ECA). THE PHYSICIAN SET UP WAS AS FOLLOWED: BENCHMARK¿ 6F 95CM DELIVERY CATHETER (PENUMBRA), MIDWAY¿ 43 INTERMEDIATE CATHETER (PENUMBRA), AND SL-10® MICROCATHETER (STRYKER). ALL CATHETERS WERE ON A CONTINUOUS HEPARINIZED FLUSH. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605940 ↗
• MalfunctionApr 4, 2024Product Quality Problem; Material Separation; Separation Failure; Product Quality Problem; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VESSEL SACRIFICE PROCEDURE TARGETING THE RIGHT VERTEBRAL ARTERY TO LIMIT BLOOD FLOW TO A TUMOR, THE SECOND COIL THE PHYSICIAN TRIED TO IMPLANT, A 2MM X 8CM CEREPAK HELIFORM XTRASOFT ((B)(6)) DID NOT DETACH. THE PHYSICIAN COULD NOT FIND THE DETACHMENT MARKER ON FLUORO IMAGING. THE MARKER MAY HAVE BEEN ADVANCED TOO FAR OUT OF THE CONCOMITANT MICROCATHETER, A PNOVUS¿ 17 MICROCATHETER (WALLABY-PHENOX), AND INTO THE COIL MASS, OR THE MARKER COULD HAVE BEEN TOO PROXIMAL AND OFFSCREEN. IT WAS REPORTED THAT THE PHYSICIAN WAS ADAMANT THAT THIS COIL DID NOT HAVE ANY DETACHMENT MARKER. THE PROXIMAL END OF THE HYPOTUBE BROKE OFF DURING MANUAL BREAK AND ALSO SHEARED THE WIRE. THE PHYSICIAN ATTEMPTED AND FAILED TO DETACH THE PULL WIRE WITH FORCEPS. THE PHYSICIAN REMOVED THE NON-DETACHED COIL. LATER IN THE PROCEDURE, ANOTHER COIL, A 4MM X 15CM CEREPAK HELIFORM XL ((B)(6)) ALSO DID NOT DETACH. THE PROXIMAL END OF THE HYPOTUBE BROKE OFF DURING MANUAL BREAK AND AGAIN SHEARED OFF THE WIRE AT THE BREAKPOINT. THE PHYSICIAN ATTEMPT AND FAILED TO DETACH THE PULL WIRE WITH FORCEPS. THE PHYSICIAN REMOVED THE NON-DETACHED COIL. THE PROCEDURE WAS REPORTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046011 ↗
• MalfunctionFeb 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN ATTEMPTED TO PLACE FIVE (5) COILS VIA A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 101456956) WITH THE LAST OF THE FIVE COILS VIA MANUAL BREAK. IT WAS REPORTED THAT ALL FIVE COILS FAILED TO DETACH. THE PHYSICIAN DECIDED TO USE ORBIT GALAXY COILS USING THE SAME STRAIGHT SL-10 MICROCATHETER WITH SUCCESS. THE FOLLOWING FOUR (4) COILS WERE USED WITH THE MECHANICAL DETACHMENT HANDLE: A 3.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR123505 / 31146338), A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168), A 2.5MM X 3.5CM CEREPAK FREEFORM XTRASOFT (XCR122535 / 31140719), AND ANOTHER 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168). THE FIFTH COIL THAT FAILED TO DETACH VIA MANUAL BREAK WAS A 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31112710). NONE OF THE COILS WERE OBSERVED STRETCHED WHEN THEY WERE REMOVED. ALL FIVE COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691803 ↗
• MalfunctionFeb 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN ATTEMPTED TO PLACE FIVE (5) COILS VIA A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 101456956) WITH THE LAST OF THE FIVE COILS VIA MANUAL BREAK. IT WAS REPORTED THAT ALL FIVE COILS FAILED TO DETACH. THE PHYSICIAN DECIDED TO USE ORBIT GALAXY COILS USING THE SAME STRAIGHT SL-10 MICROCATHETER WITH SUCCESS. THE FOLLOWING FOUR (4) COILS WERE USED WITH THE MECHANICAL DETACHMENT HANDLE: A 3.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR123505 / 31146338), A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168), A 2.5MM X 3.5CM CEREPAK FREEFORM XTRASOFT (XCR122535 / 31140719), AND ANOTHER 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168). THE FIFTH COIL THAT FAILED TO DETACH VIA MANUAL BREAK WAS A 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31112710). NONE OF THE COILS WERE OBSERVED STRETCHED WHEN THEY WERE REMOVED. ALL FIVE COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691774 ↗
• MalfunctionJan 19, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING ¿A VERY COMPLICATED¿ RECANALIZED LARGE LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH MILD VESSEL TORTUOSITY, A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31162599) WAS ADVANCED THROUGH A HEADWAY® DUO 156 MICROCATHETER (MICROVENTION) WITHOUT RESISTANCE. THE PHYSICIAN ATTEMPTED TO USE THE MANUAL DETACHMENT APPROACH. IT WAS REPORTED THAT BREAKING THE COIL AT THE SCORING MARK WAS DIFFICULT AND THE PULL WIRE BROKE; FORCEPS WERE USED IN AN UNSUCCESSFUL ATTEMPT TO PULL THE PULL WIRE BACK. THE COIL DID NOT DETACH AND THE SYSTEM WAS TAKEN OUT WITH THE COIL INTACT. A 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530 / 31136144) WAS ADVANCED THROUGH THE SAME MICROCATHETER WITH MINIMAL FRICTION AROUND THE MANUAL BREAK MARKS. THE MANUAL BREAK WAS ATTEMPTED. THE COIL DETACHED INSIDE THE MICROCATHETER AND THE COIL WAS PUSHED FORWARD INTO THE ANEURYSM USING THE DELIVERY SYSTEM. THE COIL WAS LEFT IN THE ANEURYSM AND TREATED AS AN IMPLANT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. PER THE COMPLAINT INFORMATION, ONLY THE 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208) IS AVAILABLE FOR RETURN; TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548095 ↗
• MalfunctionDec 5, 2023Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY (PCOM), A HELIFORM XSFT XL 2MM X 8 CM COIL (XHE120208, 31162599) WAS PLACED THROUGH ECHELON 10 MICROCATHETER (MC) AND MANUAL BREAK WAS ATTEMPTED. THE COIL DID NOT DETACH AND GOT STUCK WITHIN THE MICROCATHETER. IT WAS REMOVED AS A UNIT. ADDITIONAL INFORMATION RECEIVED ON 04-DEC-2023 INDICATING THAT FIVE COILS WERE PREVIOUSLY IMPLANTED. ONLY MANUAL BREAK WAS ATTEMPTED USING THE DETACHMENT HANDLE. NO NOTABLE DAMAGE WAS SEEN ON THE COIL. THE VESSEL WAS ¿NORMAL¿. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURAL DELAY WAS OF ONE MINUTE TO EXCHANGE CATHETERS SINCE IT WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265875 ↗