CEREPAK FREEFORM SCR120306Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704083092), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Material Separation; Separation Failure; Material Separation; Separation Failure

  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 18080845 ↗