Galeo Pro MRecalls & reported problems
Concert Medical, LLC · Coronary Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814384020239), received between Dec 26, 2018 and Mar 17, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2021Fracture; Fracture
PHYSICIAN REPORTED THAT, AFTER CROSSING THE AORTA, THE GUIDING CATHETER ENTERED A PERIPHERAL ARTERIA. WHEN THE PHYSICIAN REMOVED THE GUIDEWIRE, THE DISTAL PORTION OF THE DEVICE BROKE AND REMAINS IN THE ARTERY. USER ALSO REPORTS THAT THIS INCIDENT HAPPENED WITH THE SAME DEVICE SOME DAYS BEFORE.
Patient problems: Foreign Body In Patient
MAUDE report 11509813 ↗MalfunctionDec 26, 2018Fracture; Fracture
DISTAL TIP OF GUIDEWIRE FRACTURED DURING PCI PROCEDURE. DETACHED TIP WAS LEFT BEHIND IN THE PATIENT'S LATERAL CORONARY VESSEL; NO ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE GUIDEWIRE FRAGMENT. THE PHYSICIAN REPORTED THAT THE PATIENT WAS DISCHARGED HOME WITH NO MEDICAL COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8198140 ↗
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- 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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