CEREPAK HELIFORMRecalls & reported problems across all models
Cerenovus, Inc. · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CEREPAK HELIFORM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 48 models of CEREPAK HELIFORM by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2023 and Jun 18, 2025 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (17 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CEREPAK HELIFORM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 48 of these models · Recall details · FDA record ↗
Most reported CEREPAK HELIFORM problems
Device problems
- Separation Failure17
- Material Separation2
- Failure to Advance1
- Product Quality Problem1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
CEREPAK HELIFORM models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CEREPAK HELIFORM XHE120208DEVICE, NEUROVASCULAR EMBOLIZATION1 recall7 reports
- CEREPAK HELIFORM SHD180312DEVICE, NEUROVASCULAR EMBOLIZATION1 recall2 reports
- CEREPAK HELIFORM SHD180415Device, Vascular, for Promoting Embolization1 recall2 reports
- CEREPAK HELIFORM XHE120204Device, Vascular, for Promoting Embolization1 recall2 reports
- CEREPAK HELIFORM XHE120206DEVICE, NEUROVASCULAR EMBOLIZATION1 recall2 reports
- CEREPAK HELIFORM SHD180520DEVICE, NEUROVASCULAR EMBOLIZATION1 recall1 report
- CEREPAK HELIFORM SHD181445Device, Vascular, for Promoting Embolization1 recall1 report
- CEREPAK HELIFORM SHD100154DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100208Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100250DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100258DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100308DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100310DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100408Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100410DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100510Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100515Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100612Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100616Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100716Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100720DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD100820Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD100925DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD180625DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD180733DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD180835Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD180935Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD181040DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD181242DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD181650Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD181855Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD182060DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM SHD182260Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM SHD182460DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100151Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100152DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100153DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100201Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100202Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100203DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100204Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100206DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100254DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100256Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100304Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100306Device, Vascular, for Promoting Embolization1 recall0 reports
- CEREPAK HELIFORM XHD100406DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
- CEREPAK HELIFORM XHD100408DEVICE, NEUROVASCULAR EMBOLIZATION1 recall0 reports
Recent CEREPAK HELIFORM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Separation Failure; Separation Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA), A HELIFORM XSFT XL 2MM X 4 CM COIL (XHE120204, 31434959) WAS USED THROUGH A PLATO 17 160CM. THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) WAS USED FOR THE FIRST DETACHMENT ATTEMPT. AFTER THE FAILED DETACHMENT ATTEMPT WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS REMOVED SUCCESSFULLY. NO PATIENT HARM OR DELAY OF CARE CAME FROM THIS DETACHMENT FAILURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH THE FIRST TWO CEREPAK COILS. MILD TORTUOSITY WAS NOTED IN THE LEFT EXTRACRANIAL INTERNAL CAROTID ARTERY (LECA) AND THE LEFT MIDDLE MENINGEAL ARTERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-JUN-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE NOTED TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WERE NO PROCEDURAL ELAY/PROLONGATION DUE TO THE EVENT. IT WAS NOTED THAT THE CAUSE OF THE FAILURE TO DETACH IS UNKNOWN. THERE WERE TWO SUCCESSFUL COIL DETACHMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282663 ↗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 ↗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 21953744 ↗MalfunctionApr 21, 2025Separation Failure; Separation Failure
AS REPORTED BY THE HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO A VERTEBRAL ARTERY FISTULA, THE PHYSICIAN WAS COILING THROUGH A PLATO 017 160CM MICROCATHETER (MC). INSERTED 10 COILS PREVIOUSLY. INSERTED A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339), DURING DETACHMENT, TRIED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) BUT WAS UNSUCCESSFUL SO THE USER TURNED TO MANUAL BREAK METHOD. DURING MANUAL BREAK, PULL WIRE BROKE OFF INSIDE OF THE PUSHER TUBE, SO UNABLE TO GRASP WITH HEMOSTAT TO PULL ON THE PULL WIRE. THE COIL WAS UNABLE TO DETACH. 5 COILS WERE SUBSEQUENTLY IMPLANTED AND DETACHED WITH NO ISSUES. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO VISUAL DEFORMITIES ON THE COIL. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. IN THE PHYSICIAN'S OPINION, THERE WERE NO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872791 ↗MalfunctionMar 10, 2025Stretched; Separation Failure; Stretched; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION, A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339) DID NOT DETACH WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, UNKNOWN LOT), IT ALSO DID NOT DETACH MANUALLY. THE DOCTOR RETRIEVED THE COIL WITH NO PROBLEMS. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-FEB-2025 INDICATED THAT THREE COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THREE ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE. IT WAS NOTED THAT THE PULL WIRE OF THE DEVICE WAS STRETCHED. THERE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 CONFIRMED THAT THE COIL WAS STRETCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21561235 ↗MalfunctionDec 27, 2024Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) WITH MILD TORTUOSITY NOTED IN THE LATERAL EXTERNAL CAROTID ARTERY (LECA) AND THE LEFT MMA, A 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31393529) WAS USED THROUGH A PLATO® 17 MICROCATHETER (SCIENTIA VASCULAR). THE DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN) WAS USED FOR THE FIRST TWO DETACHMENT ATTEMPTS. AFTER THE FAILED DETACHMENT ATTEMPTS WITH THE HANDLE, THE MANUAL BREAK METHOD WAS USED, WHICH ALSO FAILED. THE COIL WAS REMOVED, AND ANOTHER COIL OF THE SAME SIZE WAS USED WITH SUCCESS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT NOR ANY DELAY IN THE PROCEDURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH TWO MORE CEREPAK COILS. ON 27-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE LOT NUMBER OF THE DETACHMENT HANDLE IS NOT KNOWN. WHEN THE COIL WAS REMOVED FROM THE PATIENT, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. ¿THE COIL WAS INSPECTED ON THE BACK TABLE AND THERE WAS NO VISIBLE DAMAGE TO THE DELIVERY SYSTEM THAT COULD HAVE CONTRIBUTED TO THE DETACHMENT FAILURE.¿ THE COIL WAS NOT STRETCHED. THERE WAS NO EVIDENCE OF BLOOD FLOW IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027290 ↗MalfunctionDec 10, 2024Separation Failure; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, IN A VERY LARGE BASILIAR ANEURYSM, THE PHYSICIAN WAS UNABLE TO DETACH A HELIFORM XL 4MM X 15 CM COIL (SHD180415, 31098462) AND A UNIFORM 4MM X 11.5 CM COIL (FCX100412, 31207070). EACH COIL WAS ATTEMPTED INITIALLY WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN). AFTER THAT WAS UNSUCCESSFUL, THE MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. EACH COIL WAS TAKEN OUT OF THE ANEURYSM WITHOUT ISSUES AND ANOTHER COIL WAS USED WITH THE SAME MICROCATHETER (PLATO 17 STRAIGHT). WITH EACH COIL, THE MICROCATHETER OUTSIDE THE BODY WAS STRAIGHT. NO NEGATIVE IMPACT ON PATIENT AND NO SIGNIFICANT DELAY IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895311 ↗MalfunctionDec 4, 2024Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO RETREAT AN ANEURYSM DUE TO RESIDUAL FILLING ON FOLLOW-UP ANGIOGRAPHY, THE MICROCATHETER WAS NAVIGATED INTO THE ANEURYSM AND A 5MM X 20CM CEREPAK HELIFORM XL (SHD180520 / 31228059) WAS INTRODUCED. AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE DETACHMENT HANDLE (MDH1 / 102109430) WIRE WITH SLOW ACTUATION TO TRANSLATE THE PULL WIRE. THE CEREPAK HELIFORM COIL DID NOT DETACH, AND THE PULL WIRE WAS NOT VISIBLY ELONGATED. DETACHMENT WAS ATTEMPTED AGAIN WITH THE DETACHMENT HANDLE AND THE PULL WIRE WAS CONFIRMED TO BE ELONGATED POST-ACTUATION. WHEN THE COIL PUSHER WAS BEING REMOVED, IT WAS NOTED THAT THE COIL WAS NOT DETACHED. THE PHYSICIAN SWITCHED TO THE MANUAL BREAK METHOD. THE OUTER TUBE WAS SNAPPED AT THE SCORE MARK WITH THE PULL WIRE STILL INTACT. LIGHT TENSION WAS USED TO ACTUATE BUT THE PULL WIRE STRETCHED. THE COIL WAS NOT DETACHED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TARGET COILS (STRYKER). THE PROCEDURE WAS DELAYED BY 10 MINUTES, BUT IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 25-NOV-2024, ADDITIONAL INFORMATION WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849033 ↗MalfunctionNov 18, 2024Separation Failure; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A VERY TORTOUS ANTERIOR CEREBRAL ARTERY (ACA), THE DOCTOR WAS UNABLE TO DETACH 3 COILS: FREEFORM MINI 1.5MM X 3CM (MCR091530, 31218790), FREEFORM MINI 1.5MM X 3CM (MCR091530, 31136144) AND A HELIFORM XSFT XL 2MM X 4 CM (XHE120204, 31317932). EACH COIL WAS ATTEMPTED INITIALLY WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN). AFTER THAT WAS UNSUCCESSFUL, THE MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. EACH COIL WAS TAKEN OUT OF THE ANEURYSM WITHOUT ISSUES AND ANOTHER COIL WAS USED WITH THE SAME MICROCATHETER (PLATO 17 STRAIGHT). WITH EACH COIL, THE MICROCATHETER OUTSIDE THE BODY WAS STRAIGHT. NO NEGATIVE IMPACT ON PATIENT AND NO SIGNIFICANT DELAY IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706693 ↗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, 2024Material Separation; Separation Failure; 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 (XHE120208 / 31162599) 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 (SHD180415 / 31098462) 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. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046161 ↗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 ↗
Other Cerenovus, Inc. products
- GALAXY G358 models · 1,386 reports · 1 recall
- CODMAN41 models · 107 reports · 22 recalls
- MICRUSFRAME47 models · 298 reports
- DELTAFILL29 models · 294 reports
- CEREPAK FREEFORM60 models · 166 reports · 1 recall
- CEREBASE3 models · 143 reports · 1 recall
- DELTAXSFT13 models · 130 reports
- CEREPAK UNIFORM58 models · 33 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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