Wholey™ WWFS35145Recalls & reported problems
Covidien LP · GW WWFS35145 WHOLEY WIRE V03 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684058602), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN INTENDED TO USE THE WHOLEY WIRE GW 145CM WITH A NON-MEDTRONIC PRODUCT. DURING THE PROCEDURE A DISSECTION WAS OBSERVED BY RADIOPAQUE STAINING PERI CORONARY SINUS. THE PHYSICIAN REPORTED THE DISSECTION WAS DUE TO THE WHOLEY WIRE. THE PATIENT WAS MONITORING FOR POSSIBLE CARDIAC TAMPONADE, IT WAS REPORTED THE DISSECTIONS SEPARATED LAYERS USUALLY COME TOGETHER IN TIME, INDEPENDENTLY OF ANY INTERVENTION. NO INTERVENTION REPORTED 2019-02-06, 12:41:20, (B)(6): COMPLAINT INFORMATION WAS RECEIVED 23 JAN 2019 - THIS IS THE NOTIFY DATE FOR THE FILE. UP TILL THEN WE DID NOT HAVE ANY INFORMATION REGARDING AN ALLEGATION.
Patient problems: Vascular Dissection
MAUDE report 8309730 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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