TiMesh 015-262-14Recalls & reported problems
Medtronic Ps Medical, Inc. · BLADE 015-262-14 FAN BURR HOLE 14MM DIA · Class 2 · Implant
All models of TiMesh (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169620551), received between Nov 29, 2022 and Nov 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Fracture1
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.
MalfunctionNov 29, 2022Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A FAN BARR HOLE. IT WAS REPORTED THAT WHEN THE PRODUCT WAS UNPACKED THERE WAS NO PROBLEM FOUND. WHEN USING THE IT CLOSE TO THE SKULL IT WAS FOUND THAT THE PRODUCT WAS BROKEN AND HAD A QUALITY PROBLEM. THE PRODUCT DID NOT HAVE CONTACT WITH THE PATIENT. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15879518 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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