CEREPAK FREEFORM XCR123575Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083788), received between Mar 21, 2024 and Oct 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 8CM CEREPAK FREEFORM (XCR123575 / 31178188) DID NOT DEPLOY AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS DELAYED BY 20 MINUTES. THE COIL WAS REMOVED AND A NEW COIL WAS INTRODUCED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 07-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A 4.3MM X 4.6MM X 5.2MM UNRUPTURED ANEURYSM LOCATED ON THE LEFT M1/M2 BIFURCATION. THE DETACHMENT ATTEMPTS WERE MADE TWO TIMES VIA THE DETACHMENT HANDLE (MDH1 / 102109430) AND TWICE VIA THE MANUAL BREAK TECHNIQUE. WHEN THE COMPLAINT COIL WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND IT WAS NOT STRETCHED. THE MICROCATHETER USED WAS A STRAIGHT TIP EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE REPLACEMENT COIL WAS A 3MM X 6CM CEREPAK FREEFORM XTRASOFT (XCR120306). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT. PER THE INFORMATION, THE PHYSICIAN DID NOT CONSIDER THE REPORTED 20-MINUTE DELAY TO BE CLINICALLY SIGNIFICANT, BUT ¿SHE DID NOT APPRECIATE THE DELAY AND HAVING TO REMOVE THE COIL, TO SWITCH OUT FOR DIFFERENT COIL. BEING THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502164 ↗
• MalfunctionMar 21, 2024Break; Separation Failure; Break; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA), THE 3MM X 8CM CEREPAK FREEFORM COIL (XCR123575 / 31178188) WAS DEPLOYED INTO THE ANEURYSM AND SUBSEQUENTLY DID NOT DETACH WITH MANUAL DETACHMENT. WHEN THE PHYSICIAN TRIED TO PULL THE WIRE AGAIN UPON RE-DEPLOYMENT, THE WIRE BROKE. THE COIL WAS REMOVED. THE NEXT COIL, A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / 31112709) WAS ADVANCED, BUT THE DELIVERY WIRE BECAME BENT AND IT WAS REMOVED WITHOUT DEPLOYMENT. TWO MORE COILS WERE PLACED WITHOUT DIFFICULTY AND THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 06-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, IT IS NOT KNOWN IF THE COIL WAS STRETCHED WHEN IT WAS REMOVED BECAUSE ¿IT WAS PULLED THROUGH THE RHV.¿ THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE CONCOMITANT MICROCATHETER USED WAS A 150CM X 50CM PROWLER 14 (606151FX / LOT# UNKNOWN); THE SAME MICROCATHETER WAS USED WITH THE NEXT COIL, 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / 31112709). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956557 ↗