CEREPAK FREEFORM SCR120721Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704083207), received between Nov 15, 2023 and Jun 17, 2024 — classified as 1 injury, 2 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.

• InjuryJun 17, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A FREEFORM 7MM X 15 CM (SCR120715/31058142), A FREEFORM 7MM X 21 CM (SCR120721/31131258), A MECHANICAL DETACHMENT HANDLE (MDH1/97988374), AND A FREEFORM 7MM X 21 CM (SCR120721/31131258), WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM AT THE M1 BIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FROM THE MECHANICAL DETACHMENT HANDLE. FOR THE FIRST COIL USED (COIL 7MM X 15CM FREEFORM), THE USER REPORTED A KINK/BEND IN THE CEREPAK DELIVERY TUBE AND COIL POSITIONING / STABILITY DIFFICULTY WITH LOSS OF CEREBRAL TARGET. FOR THE SECOND COIL USED (COIL 7MM X 21CM), THE USER REPORTED A KINK/BEND -IN PATIENT TO THE CEREPAK DELIVERY TUBE AND COIL - FAILURE TO DETACH. FOR THE THIRD COIL USED (SECOND COIL 7MM X 21CM), THE USER REPORTED FAILURE TO DETACH AND PREMATURE DETACHMENT-IN MICROCATHETER DURING REMOVAL. DURING THE REMOVAL OF THE LAST COIL, THE COIL DETACHED/ BROKE AND FLOATED INTO THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. SEVERAL ATTEMPTS TO RETRIEVE THE COIL PROVED TO BE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN USED AN ATLAS STENT (STRYKER

  Patient problems: Fatigue; Stroke/CVA

  MAUDE report 19547289 ↗
• MalfunctionJun 17, 2024Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A FREEFORM 7MM X 15 CM (SCR120715/31058142), A FREEFORM 7MM X 21 CM (SCR120721/31131258), A MECHANICAL DETACHMENT HANDLE (MDH1/97988374), AND A FREEFORM 7MM X 21 CM (SCR120721/31131258), WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM AT THE M1 BIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FROM THE MECHANICAL DETACHMENT HANDLE. FOR THE FIRST COIL USED (COIL 7MM X 15CM FREEFORM), THE USER REPORTED A KINK/BEND IN THE CEREPAK DELIVERY TUBE AND COIL POSITIONING / STABILITY DIFFICULTY WITH LOSS OF CEREBRAL TARGET. FOR THE SECOND COIL USED (COIL 7MM X 21CM), THE USER REPORTED A KINK/BEND -IN PATIENT TO THE CEREPAK DELIVERY TUBE AND COIL - FAILURE TO DETACH. FOR THE THIRD COIL USED (SECOND COIL 7MM X 21CM), THE USER REPORTED FAILURE TO DETACH AND PREMATURE DETACHMENT-IN MICROCATHETER DURING REMOVAL. DURING THE REMOVAL OF THE LAST COIL, THE COIL DETACHED/ BROKE AND FLOATED INTO THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. SEVERAL ATTEMPTS TO RETRIEVE THE COIL PROVED TO BE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN USED AN ATLAS STENT (STRYKER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547181 ↗
• MalfunctionNov 15, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE IN A HIGHLY TORTUOUS ANATOMY TARGETING A DISTAL M2 WIDE NECK (PARENT VESSEL OF THE M2 IS 1.5MM) 9MM X 6MM ANEURYSM THAT REQUIRED A NEUROFORM ATLAS® STENT SYSTEM (STRYKER), AFTER FRAMING THE ANEURYSM WITH A MICRUSPHERE COIL, THE PHYSICIAN CHOSE TO USE A 7MM X 13.9CM CEREPAK UNIFORM COIL (FCX100713 / 31098464) FOR THE SECOND COIL. MINOR RESISTANCE WAS NOTED WHEN PUSHING THE COIL THROUGH THE INTRODUCER SHEATH TOWARDS THE MANUAL BREAK AREA OF THE WIRE. THE PHYSICIAN NOTED THAT THE COIL UNSHEATHED WITHOUT A KINK IN THE WIRE. THE CEREPAK UNIFORM COIL DID NOT DETACH AFTER THREE ATTEMPTS WITH THE CEREPAK DETACHMENT HANDLE (MDH1 / 102109430). MANUAL BREAK OF THE COIL WAS ATTEMPTED WITHOUT SUCCESS. THE CEREPAK UNIFORM COIL WAS COMPLETELY REMOVED. IT WAS REPORTED THAT THE COIL WAS UNSTRETCHED AND INTACT. THE NEXT COIL USED IN THE CASE WAS A 7MM X 21CM CEREPAK FREEFORM (SCR120721 / 31131258). THERE WAS NO ISSUE UNSHEATHING OR ADVANCING THE COIL. HOWEVER, THE FREEFORM COIL DID NOT DETACH AFTER ONE ATTEMPT WITH THE ORIGINAL HANDLE (FROM LOT 102109430). A SECOND CEREPAK DETACHMENT HANDLE (MDH1 / 1014566956) WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145746 ↗