Guidewire SGW-060-01Recalls & reported problems
Galt Medical Corp. · Guidewire · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841268100480), received between Feb 26, 2018 and Jan 4, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Entrapment of Device1
- Material Separation1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2019Break; Device Dislodged or Dislocated
HEALTH PROFESSIONAL SENT A COMPLAINT REPORT TO THE CUSTOMER STATING THAT "WHILE ADVANCING THE GUIDEWIRE INTO THE TIBIAL VESSEL, THE GOLD TIP BECAME DISLODGED FROM GUIDEWIRE. NO EXCESSIVE TORQUE WAS BEING APPLIED." THE CUSTOMER INFORMED MANUFACTURER THAT "THE TIP BROKE OFF DURING INSERTION AND REMAINS IN THE PATIENTS LOWER LEG (LOWER TIBIA)".
Patient problems: Foreign Body In Patient
MAUDE report 8218471 ↗MalfunctionDec 24, 2018Break
AS RECEIVED FROM CUSTOMER: THE 5CM GOLD TIP BROKE OFF IN THE PATIENT AS THE WIRE WAS BEING POSITIONED. WIRE WAS LEFT IN AN ACCESSORY VESSEL OF PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8194407 ↗MalfunctionOct 4, 2018Break; Detachment of Device or Device Component
AS RECEIVED FROM CUSTOMER BY END USER: 5CM GOLD TIP BROKE OFF IN THE PATIENT AS WIRE WAS TURNED TO NAVIGATE THE VESSEL, WIRE TIP BROKE OFF IN THE PATIENT WHILE POSITIONING DOWN THE LEG. APPROX. 5CM OF WIRE REMAINS IN THE PATIENT AND WAS STENTED/PINNED TO THE VESSEL WALL. ACTION TAKEN BY PHYSICIAN WAS STENTED / PINNED WIRE TIP TO VESSEL WALL AND THE ADVERSE EVENT WAS RESOLVED.
Patient problems: Foreign Body In Patient
MAUDE report 7936758 ↗MalfunctionFeb 26, 2018Entrapment of Device; Material Separation
AS RECEIVED FROM END USER THROUGH THE CUSTOMER (PHYSICIAN WAS IN THE MIDDLE OF TREATING A POPLITEAL LESION, THROUGH A 5-6 SLENDER SHEATH. TIGHT AND TORTUOUS ANATOMY. HE WAS USING A CROSSER AND AS HE PULLED BACK TO THE TIBIA, HE NOTICED THE WIRE TIP HAD SEPARATED FROM THE WIRE SHAFT. (NOT SURE WHERE THE SEPARATION OCCURRED) MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE WIRE, BUT HE ENDED UP TRAPPING THE TIP UNDER A SHEATH).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7298088 ↗
Other Wire, Guide, Catheter devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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