Guidewire SGW-056-02Recalls & reported problems
Galt Medical Corp. · Guidewire · Class 2
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 00841268101425), received between Jun 3, 2025 and Jun 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Material Integrity Problem; Material Integrity Problem
A MANDRIL GUIDEWIRE (SGW-056-02, LOT # G24108663) WAS OPENED ADVANCED THROUGH A 4F VASCULAR SHEATH FOR PICC EXCHANGE. THE TIP BECAME LODGED WHILE TRAVERSING THROUGH THE VASCULATURE CENTRALLY. SOME RESISTANCE WAS FELT DURING ATTEMPT TO GENTLY RETRACT THE GUIDEWIRE. THE WIRE WAS THEN OBSERVED TO BE FRACTURED. A PORTION OF THE GUIDEWIRE DETACHED UPON REMOVAL, LEAVING A PORTION IN THE LEFT BASILIC VEIN AS CONFIRMED WITH FLUOROSCOPY. FOREIGN BODY RETRIEVAL: VASCULAR SNARE DEPLOYED TO RETRIEVE GUIDEWIRE FRAGMENT. MOSTLY SUCCESSFUL, BUT A FRAGMENT STILL REMAINED WITHIN THE PATIENT. VASCULAR STENT DEPLOYED TO EXCLUDE GUIDEWIRE FRAGMENT FROM THE PATIENT'S CIRCULATION. ANGIOPLASTY ALSO PERFORMED. ULTIMATELY, NO CHANGE TO PATIENT CARE MANAGEMENT.
Patient problems: Insufficient Information
MAUDE report 22136367 ↗
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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
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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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