CEREPAK FREEFORM XCR120610Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 6 mm Coil Length - 10 cm · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704083719), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Separation Failure; Separation Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA), A FREEFORM XSFT 6MM X 10 CM COIL (XCR120610, 31173119) FAILED TO DETACH. A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) FAILED. THE COIL WAS REMOVED WITHOUT INCIDENT. REPLACED WITH A CEREPAK FF XSFT 4X10 COIL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-APR-2025 INDICATED THAT A SL-10 MICROCATHETER (MC) WAS USED. TWO COILS WERE PREVIOUSLY IMPLANTED. THE MICROCATHETER WAS RE POSITIONED. THE COIL WAS BEING PLACED IN A TIGHT AREA WITH SOME MICROCATHETER KICK BACK. THERE WAS NO PROBLEM WITH ADVANCEMENT IN THE MICROCATHETER. TWO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. THERE WAS NO VISIBLE DAMAGE TO THE EMBOLIC COIL. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN MENTIONED THAT THE FORCE USED TO GET THE COIL INTO PLACE ALONG WITH THE MICROCATHETER KICK BACK COULD HAVE BEEN A FACTOR IN THE FAILURE TO DETACH. THE PROCEDURE WAS DELAYED BY 3 TO 4 MINUTES, WITH NO CLINICAL SIGNIFICANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942127 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.