WATTSON IPN916283Recalls & reported problems
Teleflex Incorporated · Wattson Temporary Pacing Guidewire Pouch · Class 2
Data updated Oct 16, 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 10841156108885), received between Nov 1, 2024 and Nov 1, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BY CLINICAL STAFF AT THE HOSPITAL: "THE DEVICE WAS USED ON A TAVR PROCEDURE. PATIENT LEFT THE ROOM AND WAS STABLE. THE PHYSICIAN SAW THE PATIENT THE NEXT DAY AND SHE WAS IN GOOD SPIRITS READY TO BE DISCHARGED. 30 MINUTES LATER SHE CODED. THEY DID CPR AND BROUGHT HER BACK TO THE CATH LAB. IT WAS AN APPARENT EFFUSION, SO THEY CRACKED HER CHEST ON THE TABLE AND THE CARDIOTHORACIC SURGEON SAW THERE WAS A SMALL HOLE IN THE VENTRICLE. SHE SUBSEQUENTLY DIED." OTHER RELEVANT ADDITIONAL INFORMATION PROVIDED BY CLINICAL STAFF AT THE HOSPITAL: "THERE WAS NO ISSUES OR COMPLICATIONS WITH DELIVERING THE WIRE DURING THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE TIP OF THE DEVICE AFTER THE PROCEDURE. THE EFFUSION WAS NOT PRESENT AFTER THE TAVR DEPLOYMENT. THE PATIENT BECAME HYPOTENSIVE PRIOR TO CODING. THE PHYSICIAN SAID THAT THIS WOULD HAVE HAPPENED WITH ANY WIRE HE WOULD HAVE USED, THEY FELT THAT THE WATTSON WAS NOT AT FAULT."
Patient problems: Insufficient Information
MAUDE report 20587593 ↗
Other Wire, guide, catheter devices
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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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