SV WIRE 503658Recalls & reported problems
Cordis Corporation · PGW .018 SV INTER 180CM ST · Class 2
All models of SV WIRE (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032056076), received between May 26, 2021 and Jul 7, 2023 — classified as 1 injury, 1 malfunction.
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
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2023Fracture; Material Frayed; Fracture; Material Frayed
AS REPORTED, THE DISTAL TIP OF A .018 180CM SV STRAIGHT TIP 8CM DISTAL TAPER GUIDEWIRE WAS FOUND FRAYED WHILE INSIDE OF THE PATIENT. THE SV - 8 GUIDEWIRE WAS REMOVED IN ONE PIECE, AND AN UNKNOWN GUIDEWIRE WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PATIENT SHOWED NO SIGNS OF INFECTIOUS DISEASE. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17277072 ↗InjuryMay 26, 2021Fracture; Fracture
DURING THE INTERVENTION AND EXTRACTION OF THE .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) POSITIONED IN THE APEX OF THE LEFT VENTRICLE OF THE HEART, A RUPTURE BETWEEN HARD AND SOFT PART OF THE GUIDEWIRE OCCURRED. FOLLOWING BY ¿DESPIRELIZATION¿ OF THE SOFT PART OF THE GUIDEWIRE. THE BROKEN PIECE OF THE GUIDEWIRE WAS SUCCESSFULLY EXTRACTED FROM THE PATIENT. THE USED DEVICE AND ONE UNUSED DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11883300 ↗
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.
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