Galeo Pro HFRecalls & reported problems
Concert Medical, LLC · Coronary Guidewire · Class 2
Data updated Oct 16, 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 00814384020192), received between Oct 20, 2016 and Oct 20, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flaked” (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 16, 2026.
Most reported problems
Device problems
- Flaked1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2016Flaked; Flaked
DURING A COMPLEX PCI JUST AFTER DILATION OF THE OSTIUM OF THE LAD IT WAS NOTICED THAT THE PTFE COATING OF THE GUIDEWIRE HAD COME OFF OF THE PART OF THE WIRE JUST OUTSIDE THE GUIDING CATHETER. WHILE REMOVING THE BALLOON CATHETER FURTHER PARTS OF THE COATING CAME LOOSE. NO PATIENT INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED, AND THE USER DID NOT REPORT THAT ANY PIECES OF THE COATING WERE LEFT IN THE PATIENT. THE PATIENT WAS DISCHARGED HOME FOLLOWING COMPLETION OF THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6044059 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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