Galeo Pro FRecalls & reported problems
Concert Medical, LLC · Coronary Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814384020215), received between Oct 18, 2016 and Jan 11, 2017 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method2
- Flaked1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Obstruction/Occlusion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2017Flaked; Flaked
PTFE COATING SEPARATED FROM THE GUIDEWIRE. NO PATIENT INJURY OR OTHER COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6241522 ↗MalfunctionNov 8, 2016Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
GUIDEWIRE FRACTURED DURING WITHDRAWAL. FRAGMENT WAS RETRIEVED USING A SNARE.
Patient problems: Foreign Body In Patient
MAUDE report 6086047 ↗MalfunctionOct 20, 2016Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE DISTAL RADIOPAQUE PORTION OF THE GUIDEWIRE BECAME KINKED DURING USE. THE PHYSICIAN CONTINUED THE PROCEDURE USING THE KINKED GUIDEWIRE, WHICH WAS WITHDRAWN INTO THE GUIDE CATHETER THEN ADVANCED DISTALLY. AFTER CROSSING THE LESION THE DISTAL PORTION OF THE GUIDEWIRE FRACTURED AND REMAINED IN THE CORONARY ARTERY. THE USER REPORTED THAT THE VESSEL MAY HAVE SPASMED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED PORTION OF THE GUIDEWIRE TIP WITHOUT SUCCESS. A STENT WAS PLACED TO ENTRAP THE GUIDEWIRE FRAGMENT AGAINST THE VESSEL WALL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6044049 ↗InjuryOct 18, 2016Fracture; Fracture
GUIDEWIRE FRACTURED AT THE JUNCTION POINT BETWEEN THE RADIOPAQUE AND THE NON-RADIOPAQUE PARTS. DURING GUIDEWIRE MANIPULATION THERE WAS NO UNUSUAL RESISTANCE. THE FRACTURE WAS NOTICED AT THE TIME OF GUIDEWIRE WITHDRAWAL. CABG PROCEDURE WAS PERFORMED DUE TO FAILED PCI.
Patient problems: Obstruction/Occlusion
MAUDE report 6037616 ↗
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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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