Wholey™ WWIJ35145Recalls & reported problems
Covidien LP · GW WWIJ35145 WHOLEY WIRE V04 · 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 00763000185695), received between May 21, 2024 and Nov 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Deformation1
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.
MalfunctionNov 20, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE WHOLEY WIRE INT J GUIDEWIRE 145CM, THE SPRING CAME OFF THE WIRE WHILE IN THE PATIENT, CAUSING THE WIRE TO BREAK APART WITHIN THE CATHETER. THE DETACHED COMPONENT REMAINED WITHIN THE CATHETER AND WAS RETRIEVED BY REMOVING THE ENTIRE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW WHOLEY GUIDEWIRE.. THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605894 ↗MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A WHOLEY WIRE GUIDEWIRE DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THE SPRING CAME OFF THE WIRE WHICH CAUSED THE WIRE TO COME APART IN THE CATHETER INSIDE THE PATIENT. THE SPRING WAS NOT RELEASED INTO THE BODY AS IT WAS STILL IN THE CATHETER. THE CATHETER AND SPRING WERE SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19358173 ↗
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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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