CEREPAK FREEFORM XCR120202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704083627), received between Jun 26, 2023 and Jul 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY, THE DOCTOR TRIED TO DETACH A FREEFORM XSFT 2MM X 2 CM COIL (XCR120202, 31118008) WITH THE DETACHER HANDLER AND IT FAILED. HE THEN WENT TO THE MANUAL BREAK AND PULLED 1 CENTIMETER ON THE PULL WIRE THEN RECHECKED WITH FLURO TO SEE IF IT WAS DETACHED AND IT WAS NOT. HE THEN TRIED TO PULL FOR ONE MORE CENTIMETER THEN RECHECKED UNDER FLURO, THE COIL WAS STILL NOT DETACHED AND THEN HE TRIED TO PULL FURTHER AT WHICH POINT HE SAID THAT IT WAS PULLING OUT VERY EASILY, SO HE STOPPED TO FLURO AND THE COIL WAS STILL ATTACHED. THEREFORE, HE REMOVED THE COIL FROM THE PATIENT BECAUSE IT WOULD NOT DETACH. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-JUL-2025 INDICATED THAT A PROWLER SELECT LP-ES MICROCATHETER WAS USED. TWO COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. TWO ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE DEVICE DEFICIENCY DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459881 ↗
• MalfunctionDec 31, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2024, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A SPINAL ARTERY WITH POLYVINYL ALCOHOL (PVA). IT WAS REPORTED THAT THIRTEEN (13) CEREPAK FREEFORM COILS WERE USED. OF THE THIRTEEN (13) COILS, ONE COIL, A 2MM X 2CM CEREPAK FREEFORM XTRASOFT (XCR120202 / LOT# 31112711) WOULD NOT DETACH VIA MANUAL BREAK NOR WITH THE DETACHMENT HANDLE (MDH1 / 102109430). THE COIL WAS REMOVED WITHOUT ANY ISSUE. THE COMPLAINT COIL WILL BE RETURNED FOR EVALUATION AND ANALYSIS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE 64-YEAR-OLD FEMALE PATIENT WAS REPORTEDLY DOING FINE POST-OP. ON 16-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE SAME DETACHMENT HANDLE WAS USED WITH THE OTHER 12 CEREPAK COILS. WHEN THE 2MM X 2CM CEREPAK FREEFORM WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED; IT WAS NOT STRETCHED. THE 2MM X 2CM CEREPAK FREEFORM WAS REPLACED WITH ANOTHER 2MM X 2CM CEREPAK FREEFORM. THE CONCOMITANT MICROCATHETER USED WAS A PROWLER 160CM (MC2165S2U / 31075894). THERE WAS NO BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE REPORTED ISSUE DID NOT CAUSE ANY DELAY IN THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048468 ↗
• MalfunctionJun 26, 2023Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THIS WAS A COIL EMBOLIZATION TO AN ANEURYSM AT THE DISTAL INTERNAL CAROTID ARTERY (ICA) TERMINUS MEASURING APPROXIMATELY 4 X 3.5 X 2 WITH A NECK OF ALMOST 4MM WITH USE OF AN ATLAS STENT. THE ISSUE HAPPENED WHEN THE SECOND COIL USED, A FREEFORM XSFT 2MM X 2 CM (XCR120202, 31036606) WOULD NOT DETACH USING THE HANDLE TWICE AND THE MANUAL DETACHMENT ALSO WAS UNSUCCESSFUL. THE COIL WAS ADVANCED THROUGH THE SHEATH AND UNSPECIFIED MICROCATHETER WITHOUT ISSUE. AFTER THE FIRST ATTEMPT OF THE HANDLE, THE COIL WAS ADVANCED A FEW MILLIMETERS FURTHER AND ATTEMPTED AGAIN WITH THE HANDLE. THE MANUAL DETACHMENT WAS ATTEMPTED AS SUGGESTED BY THE INSTRUCTIONS FOR USE (IFU) ALSO UNSUCCESSFUL. THE COIL WAS TAKEN OUT OF THE ANEURYSM. THE COIL APPEARS TO BE INTACT AND NOT STRETCHED. ANOTHER COIL OF THE SAME SIZE AND LOT NUMBER WAS USED AS EXPECTED. NO IMPACT TO PATIENT AND MINIMAL TIME DELAYS DUE TO THIS DETACHMENT ISSUE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CONCOMITANT DEVICES FUNCTION AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199074 ↗