CEREPAK FREEFORM SCR120615Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 6 mm Coil Length - 15 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704083177), received between Sep 26, 2024 and Oct 21, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Wrong Label” (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. 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
- Wrong Label3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Wrong Label; Wrong Label
IT WAS REPORTED BY THE CERENOVUS REPRESENTATIVE THAT THE DURING A PROACTIVE TRUNK STOCK INVENTORY, A CEREPAK UNIFORM COIL BOX HAS A CEREPAK FREEFORM LABEL PRINTED ON THE SPINE FOR A 6MM X 15CM CEREPAK FREEFORM (SCR120615 / 31136146). THIS IS AN INCORRECT LABEL FOR THE CEREPAK UNIFORM. THERE WAS NO FACILITY OR PATIENT INVOLVEMENT. ON 16-OCT-2024, AN EMAIL WITH THREE PHOTOS WAS RECEIVED. THE PHOTOS WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20500807 ↗MalfunctionOct 16, 2024Wrong Label; Wrong Label
AS REPORTED BY THE FIELD, DURING INSPECTION OF TRUNK STOCK, THE BOX OF A FREEFORM 6MM X 15 CM COIL (SCR120615, 31136146) WAS MISLABELED. THE BOX WAS LABELED BEING A ¿UNIFORM¿ INSTEAD OF FREEFORM. NO PATIENT INJURY WAS REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20460108 ↗MalfunctionSep 26, 2024Wrong Label; Wrong Label
AS REPORTED BY THE FIELD, WHEN PLACING CONSIGNMENT CEREPAK COILS, IT WAS NOTED THAT A FREEFORM 6MM X 15 CM COIL (SCR120615, 31136146), NOTED BY LABEL AND STICKERS, WAS RECEIVED IN A CEREPAK UNIFORM BOX. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314856 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.