WATTSON IPN914275Recalls & reported problems
Teleflex Incorporated · WattsonGuidewire,280cm · 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 10841156106492), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable Capture Threshold” (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
- Unstable Capture Threshold1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Unstable Capture Threshold
IT WAS REPORTED THAT: "VALVE EMBOLIZATION DURING TAVR PROCEDURE. WATTSON WIRE WAS SEEMINGLY FUNCTIONING PROPERLY DURING VALVE DEPLOYMENT. LOSS OF PROPER PACING WAS NOTED DURING THE FINAL MOMENT OF DEPLOYMENT, CAUSING SUDDEN MOVEMENT OF THE HEART, AND THE VALVE TO BE DISPLACED BACKWARDS INTO THE AORTA. EMBOLIZED VALVE WAS DRUG BACKWARDS INTO THE DESCENDING AORTA AND SECURED IN PLACE WITH A THORACIC ENDOGRAFT. A NEW TAVR VALVE WAS PLACED IN THE CORRECT POSITION. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THIS EVENT. A TEMPORARY-PERMANENT PACING LEAD WAS INSERTED AND SECURED INTO THE PATIENT'S RV TO PROVIDE PACING DURING THE SECOND VALVE DEPLOYMENT. A NEW EDWARDS TAVR VALVE AND DELIVERY SYSTEM WAS THEN PLACED THROUGH THE GRAFT AND UTILIZED TO DEPLOY A SECOND TAVR VALVE IN THE CORRECT POSITION ACROSS THE AORTIC VALVE.".
Patient problems: Failure of Implant
MAUDE report 23973049 ↗
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- 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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