CEREPAK FREEFORM XCR120515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704083702), received between Jan 2, 2024 and Aug 22, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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.

• MalfunctionAug 22, 2025Defective Component; Defective Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, ONE OF THE COILS USED WAS A 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515 / 31177727). THE ISSUE REPORTED WITH THIS COIL WAS THAT ¿THERE WAS NO VISIBLE MARKER ON THE COIL.¿ THE COIL DETACHED AS NORMAL AND DID NOT CAUSE ANY ISSUE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 22-AUG-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878204 ↗
• MalfunctionJan 27, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM CEREPAK FREEFORM XTRASOFT COIL (XCR120515 / 31173107) FAILED TO DETACH AFTER THREE ATTEMPTS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A WIDE-NECKED 6.5MM X 6.8MM X 7MM UNRUPTURED ANEURYSM ON THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AT THE BIFURCATION. THE INFORMATION INDICATED THAT TWO OF THE THREE ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE (MDH1 / 102109430); THE THIRD ATTEMPT WAS VIA MANUAL BREAK. THE HANDLE IS REPORTED AS NOT AVAILABLE FOR RETURN. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS NO LONGER STILL ON THE DELIVERY WIRE. THE MICROCATHETER USED WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE REPLACEMENT COIL WAS A 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510), NOT ANOTHER 5MM X 15CM CEREPAK FREEFORM XTRASOFT OF THE SAME PRODUCT CODE (XCR120515). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246968 ↗
• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT PRESENTED TO (B)(6) HOSPITAL WITH AN INTRACRANIAL HEMORRHAGE. AFTER A VERY DIFFICULT ACCESS, THE PHYSICIAN WAS ABLE TO NAVIGATE THE ANEURYSM THROUGH TORTUOUS ANATOMY. USING A HEADWAY® DUO MICROCATHETER (MICROVENTION), THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST COIL, A 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515 / 31111683). THE COIL FAILED TO DETACH WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 102109430). MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. THE COIL WAS REPLACED WITH ANOTHER 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515) FROM THE SAME LOT (31111683) HERE MANUAL BREAK AS THE FIRST METHOD OF DETACHMENT, AND IT WAS ALSO UNSUCCESSFUL. IT WAS REPORTED THAT AT THIS POINT, A 2MM X 2CM CEREPAK FREEFORM MINI (MCR092020 / 31177313) WAS ADVANCED. ONCE AGAIN, MANUAL BREAK WAS CHOSEN AT THE PRIMARY DETACHMENT METHOD, AND AGAIN, THE COIL DID NOT DETACH. AT THIS POINT, THE COIL WAS REMOVED AND THE PHYSICIAN NOTICED WHAT APPEARED TO BE ¿FILAMENT¿ RETAINED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE [THE FILAMENT] WITHOUT INCIDENT AND THE PROCEDURE WAS MOVED FORWARD USING MICROVENTION COILS. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038172 ↗
• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT PRESENTED TO TAMPA GENERAL HOSPITAL WITH AN INTRACRANIAL HEMORRHAGE. AFTER A VERY DIFFICULT ACCESS, THE PHYSICIAN WAS ABLE TO NAVIGATE THE ANEURYSM THROUGH TORTUOUS ANATOMY. USING A HEADWAY® DUO MICROCATHETER (MICROVENTION), THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST COIL, A 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515 / 31111683). THE COIL FAILED TO DETACH WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 102109430). MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. THE COIL WAS REPLACED WITH ANOTHER 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515) FROM THE SAME LOT (31111683) HERE MANUAL BREAK AS THE FIRST METHOD OF DETACHMENT, AND IT WAS ALSO UNSUCCESSFUL. IT WAS REPORTED THAT AT THIS POINT, A 2MM X 2CM CEREPAK FREEFORM MINI (MCR092020 / 31177313) WAS ADVANCED. ONCE AGAIN, MANUAL BREAK WAS CHOSEN AT THE PRIMARY DETACHMENT METHOD, AND AGAIN, THE COIL DID NOT DETACH. AT THIS POINT, THE COIL WAS REMOVED AND THE PHYSICIAN NOTICED WHAT APPEARED TO BE ¿FILAMENT¿ RETAINED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE [THE FILAMENT] WITHOUT INCIDENT AND THE PROCEDURE WAS MOVED FORWARD USING MICROVENTION COILS. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038167 ↗
• MalfunctionJan 2, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN WAS EMBOLIZING A CAROTID-CAVERNOUS FISTULA (CCF) WITH MODERATE TORTUOSITY. THE PHYSICIAN DEPLOYED A TOTAL OF 12 COILS AD THEN USED ONYX¿ 34 LIQUID EMBOLIC AND ONYX¿ 18 LIQUID EMBOLIC (MEDTRONIC). THE FOLLOWING THREE COILS: 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510 / 31146337), 5MM X 15CM CEREPAK FREEFORM XSFT (XCR120515 / 31173107), AND 4MM X 12CM CEREPAK FREEFORM (SCR120412 / 31140706) DID NOT DETACH UTILIZING THE MANUAL DETACHMENT. IT WAS REPORTED THAT BREAKING OF THE MANUAL BREAK WAS DIFFICULT, BUT ULTIMATELY IT WAS ABLE TO EXPOSE THE PULL WIRE AND PULL BACK THE WIRE TO ATTEMPT TO DETACH THE COIL. THE DIFFICULTY WITH THE BREAKING OF THE MANUAL BREAK AT THE SORTING HAPPENED ON ALL COILS DOCUMENTED IN THIS COMPLAINT. ALL THREE COILS WERE ABLE TO BE REMOVED WITHOUT ANY NEGATIVE PATIENT IMPACT. ONE OF THE COILS REPORTEDLY DETACHED ON THE TABLE AFTER REMOVAL. THE REPORTED ISSUE RESULTED IN MINIMAL DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432774 ↗