CEREPAK FREEFORM XCR120304Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704083634), received between Jun 26, 2023 and Feb 13, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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, TWO FREEFORM XSFT 3MM X 4 CM COIL (XCR120304, 31131259) 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. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT NO COILS WERE IMPLANTED PRIOR TO THE ATTEMPT OF THE CEREPAK COILS. THERE WAS NO DIFFICULTY ADVANCING THE COILS OR POSITIONING WITHIN THE ANEURYSM. NO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COILS OR ANY DEVICE COMPONENT. THE TARGET VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY (LICA) BIFURCATION WITH A TYPE 3 ARCH AND VERY TORTUOUS CAROTID. THE DELAY WAS ONLY SLIGHT AND NOT SIGNIFICANT ENOUGH FOR THE DOCTOR TO COMMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698233 ↗
• MalfunctionFeb 2, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, FREEFORM XSFT 3MM X 4 CM COIL (XCR120304, 31131259) 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 18634735 ↗
• MalfunctionFeb 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACCOM), TWO FREEFORM XSFT 4MM X 8 CM COILS (XCR120408, 31126838), A FREEFORM XSFT 3MM X 6 CM COIL (XCR120306, 31136147) AND A TWO FREEFORM XSFT 3MM X 4 CM COILS (XCR120304, LOT UNKNOW) AND (XCR120304, 31131259) WERE ADVANCED INTO ANEURYSM AND MANUAL DETACHMENT WAS ATTEMPTED WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. THE FREEFORM XSFT 3MM X 4 CM COILS WERE PLACED INTO THE ANEURYSM AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLE (MDH1) WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 22-JAN-2024 INDICATED THAT A STRYKER SL-10 MICROCATHETER WAS USED. THREE COILS WERE SUCCESSFULLY DETACHED WITH MANUAL DETACHMENT PRIOR TO THE FAILURE, THEN TWO FAILURES WITH 4MM X 8 CM COIL, THEN A SUCCESSFUL DETACHMENT OF TWO 3MM X 6 CM, THEN A FAILED 3MM X 6 CM , THEN TWO MORE FAILED WITH 3MM X 4 CM WITH DETACHMENT HANDLE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COILS OR ANY DEVICE COMPONENT. THERE WAS MILD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625689 ↗
• MalfunctionFeb 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACCOM), TWO FREEFORM XSFT 4MM X 8 CM COILS (XCR120408, 31126838), A FREEFORM XSFT 3MM X 6 CM COIL (XCR120306, 31136147) AND A TWO FREEFORM XSFT 3MM X 4 CM COILS (XCR120304, LOT UNKNOW) AND (XCR120304, 31131259) WERE ADVANCED INTO ANEURYSM AND MANUAL DETACHMENT WAS ATTEMPTED WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. THE FREEFORM XSFT 3MM X 4 CM COILS WERE PLACED INTO THE ANEURYSM AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLE (MDH1) WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 22-JAN-2024 INDICATED THAT A STRYKER SL-10 MICROCATHETER WAS USED. THREE COILS WERE SUCCESSFULLY DETACHED WITH MANUAL DETACHMENT PRIOR TO THE FAILURE, THEN TWO FAILURES WITH 4MM X 8 CM COIL, THEN A SUCCESSFUL DETACHMENT OF TWO 3MM X 6 CM, THEN A FAILED 3MM X 6 CM , THEN TWO MORE FAILED WITH 3MM X 4 CM WITH DETACHMENT HANDLE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COILS OR ANY DEVICE COMPONENT. THERE WAS MILD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625679 ↗
• MalfunctionNov 6, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A LEFT INTERNAL MAXILLARY ARTERY (IMAX) EMBOLIZATION WITH PARTICLES AND COILS TO SACRIFICE VESSEL; TORTUOSITY IS HIGH, A HEADWAY® 21 MICROCATHETER (MICROVENTION) IS USED. THE SECOND COIL USED WAS A 3MM X 4CM CEREPAK FREEFORM (XCR120304 / 31131259). THE COIL ADVANCED THROUGH THE MICROCATHETER WITHOUT ISSUE. AFTER THREE (3) ATTEMPTS WITH THE HANDLE, A CEREPAKTM DETACHER (MDH1 / 102109430) WITHOUT SUCCESS, THE MANUAL BREAK WAS ATTEMPTED AS SUGGESTED BY THE INSTRUCTIONS FOR USE (IFU) AND IT WAS UNSUCCESSFUL. THE COIL WAS REMOVED FROM THE VESSEL INTACT. IT WAS REPORTED THAT A THIRD COIL, A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31136064) WAS USED AND IT ADVANCED THROUGH THE MICROCATHETER WITHOUT ISSUE. AFTER THREE (3) UNSUCCESSFUL ATTEMPTS WITH THE HANDLE, THE MANUAL BREAK WAS ATTEMPTED AND THE COIL DID DETACH IN THE VESSEL. THE COIL IS BEING RETURNED BECAUSE THE HANDLE ATTEMPTS WERE WITHOUT SUCCESS. THE HANDLE WAS NOT RETAINED FOR ANALYSIS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE REPORTED ISSUES RESULTED IN MINIMAL DELAY IN TREATMENT. ON 31-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL ACCOUNT SPECIALIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080942 ↗
• MalfunctionNov 6, 2023Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 48-YEAR-OLD MALE PATIENT UNDERWENT A PHARYNGEAL-CAROTID ARTERY (CA) VESSEL SACRIFICE PROCEDURE TARGETING THE LEFT COMMON CAROTID ARTERY (LCCA), A 6FR SHEATH -RIGHT FEMORAL ARTERY, 6FR BENCHMARK¿ DISTAL ACCESS CATHETER (PENUMBRA) WITH 5FR VTK SELECT CATHETER (UNSPECIFIED BRAND) WERE INTRODUCED TO THE LCCA ALONG WITH AN EXCELSIOR® XT-27® MICROCATHETER (STRYKER) AND SYNCHRO2® 0.014¿ GUIDEWIRE (STRYKER). A 3MM-5MM MICRO VASCULAR PLUG (MVP) (MEDTRONIC) WAS DEPLOYED IN THE LCCA SEGMENT. THE EXCELSIOR® XT-27® MICROCATHETER WAS REMOVED. THE SL-10® 45° MICROCATHETER (STRYKER) AND THE SYNCHRO 14 GUIDEWIRE AT THE PROXIMAL TO WHERE THE PLUG WAS DEPLOYED WAS REMOVED. THE FOLLOWING CEREPAK FREEFORM COILS WERE PLACED: 4MM X 12CM CEREPAK FREEFORM (SCR120412 / 31140706), 5MM X 15CM CEREPAK FREEFORM (SCR120515 / 31090186), 6MM X 20CM CEREPAK FREEFORM (SCR120620 / 31058141), 6MM X 15CM CEREPAK FREEFORM (SCR120615 / 31136146), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31140705), 6MM X 20CM CEREPAK FREEFORM XTRASOFT (XCR120620 / 31131261), 4MM X 12CM CEREPAK FREEFORM (SCR120515 / 31090186), 6MM X 20CM CEREPAK FREEFORM (SCR120620 / 31058141), 6MM X 25CM CEREP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080848 ↗
• MalfunctionJun 26, 2023Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THIS WAS A RECANALIZATION TO THE BASILAR TIP ANEURYSM WITH STENT ALREADY IN PLACE. THE ISSUE HAPPENED WHEN THE FIRST COIL, A FREEFORM XSFT 3MM X 4 CM (XCR120304, 30982796) WOULD NOT DETACH USING THE HANDLE TWICE AND THE MECHANICAL DETACHMENT HANDLE (MDH1, 97988373) WAS ALSO UNSUCCESSFUL. THE COIL WAS ADVANCED THROUGH THE SHEATH AND THE HEADWAY DUO 156 CM MICROCATHETER (MC) WITH MINIMAL FRICTION. NO KINKING OF WIRE OF COIL. 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 SYSTEM PULLED OUT COMPLETELY THROUGH MANUAL DETACHMENT ZONE. THE COIL WAS TAKEN OUT OF THE ANEURYSM. THE COIL APPEARS TO BE INTACT AND NOT STRETCHED. STRYKER COILS WERE USED IN THIS CASE AFTER INCIDENT. NO IMPACT TO PATIENT AND MINIMAL TIME DELAYS DUE TO THIS DETACHMENT ISSUE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS MINIMAL DIFFICULTY POSITIONING THROUGH THE STENT. THERE WAS MODERATE VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199644 ↗