CEREPAK FREEFORM MCR092040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704083009), received between Jun 28, 2023 and Apr 21, 2025 — classified as 6 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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A TUMOR EMBOLIZATION, A FREEFORM MINI 2MM X 4CM COIL (MCR092040, 31098100) FAILED TO DETACH. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-APR-2025 INDICATED THAT THE COIL DID NOT DETACH AFTER ATTEMPTING TO USE THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) OR MANUAL BREAK ATTEMPT. THERE WERE NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS (CALCIFICATION/TORTUOSITY). THE PROCEDURE WAS COMPLETED BY USING ANOTHER CEREPAK COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874404 ↗
• MalfunctionJan 10, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31393524) AND THE 2MM X 4CM CEREPAK FREEFORM MINI (MCR092040 / 31140703) DID NOT DEPLOY WHEN PLACED PROPERLY AND MANUAL BREAK WAS ATTEMPTED. BOTH COILS WERE SUBSEQUENTLY REMOVED SAFELY AND WERE DISPOSED OF. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132229 ↗
• MalfunctionJun 21, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE FREEFORM MINI 2MM X 4CM (MCR092040/31140703) WAS BEING INTRODUCED INTO THE MICROCATHETER RESISTANCE WAS NOTED. THE COIL WAS REMOVED AND INSPECTED AND IT WAS ATTEMPTED TO BE ADVANCED AGAIN WITHOUT RESOLUTION. THE EMBOLIC COIL WAS REPLACED, AND THE ISSUE RESOLVED. ADDITIONAL EVENT INFORMATION INDICATED THAT THE RESISTANCE WAS FELT AT THE DISTAL ASPECT OF THE INTRODUCER SHEATH. A STRYKER EXCELSIOR SL-10 MICROCATHETER (NON J&J) WAS USED. A SYNCHRO WIRE AND TWO COILS WERE USED WITH THE MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE, AND A COIL AFTER THE ENCOUNTERED RESISTANCE. THERE WAS NO NECESSITY TO REMOVE NOR REPLACE THE MICROCATHETER. THE TARGET VESSEL WAS THE POSTERIOR COMMUNICATING ARTERY, AND THERE WAS TORTUOSITY. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583607 ↗
• MalfunctionApr 29, 2024Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHILE PLACING A FREEFORM MIN COIL INSIDE THE ANEURYSM, NO DETACHMENT MARKER WAS FOUND AT ALL UNDER FLUORO. THEREFORE, THE PHYSICIAN DIDN¿T KNOW WHEN TO DETACH THE COIL. THE COIL WAS REMOVED, AND CASE CARRIED ON. TWO COILS, A FREEFORM MINI 2MM X 6CM (MCR092060, 31162594) AND A FREEFORM MINI 2MM X 4CM (MCR092040, 31162593) ARE BEING INCLUDED IN THE COMPLAINT SINCE IT IS NOT CLEAR WHICH ONE HAD THE ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-APR-2024 INDICATED THAT THERE WAS NO PATIENT INJURY. THE CASE WAS FINISHED WITH ANOTHER COIL. THERE WAS A 3-MINUTE PROCEDURE DELAY DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203230 ↗
• MalfunctionFeb 26, 2024

  THIRTEEN DEVICES THAT THE COIL WOULD NOT DEPLOY ON TWO DIFFERENT PATIENTS. LOT NUMBERS: 101456956, 31146338, 31077168, 31140719, 31077168, 31112710, 31098100, 31136064, 31162597, 31162597, 31146338, 31162598, 31107820.

  Patient problems: Insufficient Information

  MAUDE report 18776969 ↗
• MalfunctionJun 28, 2023Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM TO THE MIDDLE MENINGEAL ARTERY, A FREEFORM MINI 1MM X 1.5CM COIL (MCR092040, 31045739) FAILED TO DETACH. NO PREVIOUS COILS HAD BEEN PREVIOUSLY IMPLANTED. THERE HAD NOT BEEN ANY RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE SL10 STRYKER MICROCATHETER (MC) OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE HAD BEEN THREE ATTEMPTS MADE USING THE DETACHMENT HANDLE PRIOR TO MANUAL DETACHMENT. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WAS NO VESSEL ACUTE BENDS. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS ABOUT A 20-MINUTE PROCEDURAL DELAY, WE HAD TO BRING IN THE BALT COIL CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216008 ↗