VSI IPN913185Recalls & reported problems
Teleflex Incorporated · VSI Guidewires · Class 2
All models of VSI (31)
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 10841156105815), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2022Material Fragmentation; Material Fragmentation
AS REPORTED: VAT NURSE PUTTING IN A PICC LINE. MET RESISTANCE WHEN ATTEMPTING TO FEED WIRE DOWN NEEDLE. REMOVED NEEDLE AND WIRE. OPENED TELEFLEX WIRE. GOT ACCESS AGAIN. SAME THING OCCURRED AND TRIED TO REMOVE NEEDLE AND WIRE. NEEDLE CAME OUT, BUT WIRE GOT STUCK AND PART BROKE OFF IN PATIENT. PATIENT IS REPORTED AS OK. X-RAY CONFIRMED 7MM LEFT IN PATIENT TISSUE (NOT VESSEL). DOCTORS DECIDED TO LEAVE IT RETAINED IN PATIENT. THEY WERE THEN ABLE TO GET MIDLINE IN THE OTHER ARM. THEY DID NOT SAVE THE PRODUCT FOR RETURN. ADDITIONAL INFORMATION ON 14JUL2022: GW RESISTANCE EXPERIENCED AS RN WAS ADVANCING THE GUIDEWIRE. RN THEN ATTEMPTED TO REMOVE THE GUIDEWIRE AND NEEDLE TOGETHER BUT THE GUIDEWIRE STUCK. RN SLIGHTLY TWISTED THE GUIDEWIRE AND REMOVED THE GUIDEWIRE AND NEEDLE BUT WAS ONLY ABLE TO REMOVE THE NEEDLE. RN REPORTED SHE FELT THE GUIDEWIRE SPLICED AT THE TIP. TIP OF GUIDEWIRE IS STILL IN THE SOFT TISSUE OF THE PATIENT'S LEFT ARM. IR WAS CONSULTED AND RECOMMENDED TO NOT REMOVE THE TIP AS IT MAY DO MORE HARM TO THE PATIENT. A MIDLINE WAS THEN PLACED ON THE PATIENT'S RIGHT ARM WITHOUT ANY ISSUES.
Patient problems: Foreign Body In Patient
MAUDE report 15122591 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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