Galeo Pro ES-FRecalls & reported problems
Concert Medical, LLC · Coronary Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814384020253), received between Oct 18, 2016 and Jan 11, 2017 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).
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
- Patient-Device Incompatibility2
- Flaked1
Patient problems
- Thrombus2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2017Flaked; Flaked
GUIDEWIRE WOULD NOT ADVANCE INSIDE GUIDING CATHETER. WHEN GUIDEWIRE WAS REMOVED FROM GUIDE CATHETER THE PTFE COATING ON THE GUIDEWIRE WAS FOUND TO BE DELAMINATED IN SEVERAL PLACES. NO PATIENT INJURY OR OTHER COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6241041 ↗InjuryOct 18, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
TWO STENOSES OF THE LAD WERE TREATED, THEN A TOTAL OCCLUSION OF THE LAD OCCURRED. THE GUIDEWIRE WAS REMOVED AND THE OCCLUSION WAS OPENED USING A 2ND GUIDEWIRE. ASPIRATION WAS THEN PERFORMED AND A 3RD STENT WAS IMPLANTED. THE PHYSICIAN SAID THERE WERE THROMBOTIC APPOSITIONS ON THE GUIDEWIRE.
Patient problems: Thrombus
MAUDE report 6037951 ↗InjuryOct 18, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
THE GALEO PRO GUIDEWIRE WAS USED TO CROSS TWO STENOSES IN THE LAD. DURING WITHDRAWAL OF THE GUIDEWIRE A TOTAL OCCLUSION OF THE LAD OCCURRED. THE PHYSICIAN USED AN ASPIRATION CATHETER AND TWO MORE STENTS FOR THIS OCCLUSION. THE PHYSICIAN THINKS THE 4 GUIDEWIRE WAS THE TRIGGER FOR THE THROMBUS.
Patient problems: Thrombus
MAUDE report 6037610 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page