CEREPAK FREEFORM XCR120406Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704083665), received between Jan 2, 2024 and Feb 13, 2024 — classified as 4 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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACOMM), SEVEN SUCCESSFUL DETACHMENTS OCCURRED, HOWEVER, THE EIGHT-DETACHMENT FAILED WHEN USING A FREEFORM XSFT 4MM X 6 CM COIL (XCR120406, 31107822). THE MANUAL BREAK POINT WAS BROKEN PROXIMAL ON THE BLACK MARKER. DOCTOR ATTEMPTED TO REBREAK IN CORRECT SPOT AND THE COIL DID NOT DETACH. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-FEB-2024 INDICATED THAT A SL-10 MICROCATHETER WAS USED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. NO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. WHEN HE FIRST ATTEMPTED MANUAL BREAK, HE FELT RESISTANCE AT WHAT HE THOUGHT WAS THE BREAK POINT. WHEN THEY MOVED A LIGHT OVERHEAD, HE REALIZED THE BREAK WAS AT THE WRONG LOCATION. HE THEN REALIZED HE DID NOT BREAK IT CORRECTLY AND ATTEMPTED TO BREAK IT AT THE CORRECT LOCATION. WE DID NOT EXPECT IT TO DETACH GIVEN THE DAMAGE. HOWEVER, HE DID FEEL LIKE MAYBE THE BREAKPOINT WAS OFF SLIGHTLY. SPEAKING WITH HIM AFTER THE CASE, HE FELT IT WAS DUE TO THE MISTAKE OF BREAKING IN THE WRONG SPOT BUT WANTED TO MAKE SURE THE WEAK BREAK POINT WAS NOT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695399 ↗
• MalfunctionFeb 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE BASILAR ARTERY ANEURYSM, AFTER SUCCESSFULLY PLACING ONE COIL, FOUR (4) ADDITIONAL COILS WERE USED WITH FAILED DETACHMENTS USING THE MANUAL BREAK. THE FOUR (4) COILS THAT HAD FAILED DETACHMENT ATTEMPTS WERE: A 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / (B)(6)), A 4MM X 6CM CEREPAK FREEFORM XSFT (XCR120406 / (B)(6)), A 4MM X 8CM CEREPAK FREEFORM XTRASOFT (XCR120408 / (B)(6)), AND A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / (B)(6)). THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED TO CONTINUE WITH THE DETACHER HANDLE AND SUCCESSFULLY DETACHED TEN (10) MORE COILS. THE PHYSICIAN USED A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH FLUSH LINES. IT WAS REPORTED THAT THE SYSTEM WAS STRAIGHTENED WITH NO BENDS PRIOR TO DETACHMENTS. THE SL-10® MICROCATHETER WAS USED THROUGH THE ENTIRE PROCEDURE TO ITS SUCCESSFUL CONCLUSION. THERE WAS NO PROCEDURE DELAY REPORTED AS A RESULT OF THE FAILED DETACHMENT ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681825 ↗
• MalfunctionFeb 2, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, FREEFORM XSFT 3MM X 4 CM COIL (XCR120304, (B)(6)) AND A FREEFORM XSFT 4MM X 6 CM COIL (XCR120406, UNKNOWN LOT) WOULD NOT DETACH. THREE DETACHMENTS WERE ATTEMPTED MANUAL BREAK. NO COILS WOULD DETACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634843 ↗
• MalfunctionJan 2, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A FISTULA EMBOLIZING WITH MODERATE TORTUOSITY, THE USER DEPLOYED A TOTAL OF 13 COILS. THE FOLLOWING THREE COILS DID NOT DETACH UTILIZING THE MANUAL DETACHMENT: FREEFORM 5MM X 10 CM (SCR120510, 31090185), FREEFORM XSFT 3MM X 8 CM (XCR120308, 31162597) AND FREEFORM XSFT 4MM X 6 CM (XCR120406, 31140708). BREAKING OF THE MANUAL BREAK WAS DIFFICULT. BUT WAS ULTIMATELY ABLE TO EXPOSE THE PULL WIRE AND PULL BACK THE WIRE TO ATTEMPT TO DETACH COIL. THIS DIFFICULTY WITH THE BREAKING OF THE MANUAL BREAK AT THE SCORING HAPPENED ON ALL OF THE COILS REGARDING THIS COMPLAINT. ALL THREE COILS WERE ABLE TO BE REMOVED WITHOUT PATIENT INCIDENT, ONE OF THE COILS DETACHED ON THE TABLE AFTER REMOVAL. MINIMAL DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430889 ↗