Navilyst 96000603Recalls & reported problems
Navilyst Medical, Inc. · Angiographic Guidewire, Fixed Core, Straight Tip · 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 H965960006030), received between May 18, 2016 and May 18, 2016 — 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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2016Material Fragmentation; Material Fragmentation
AS REPORTED: "SURGEON TOOK THE GUIDEWIRE, INSERTED IT AND THEY HAD DIFFICULTY PULLING IT OUT AND THE WIRE BROKE OFF. IT WAS INSERTED THRU THE R4 CATHETER AND THEY SAID THE CATHETER DID NOT ADVANCE PAST MID ARM LEVEL SO AT THAT POINT THEY DECIDED TO REMOVE THE CATHETER AND WIRE AND USE AN ALTERNATIVE GROIN APPROACH. THE CATHETER CAME OUT OF THE SHEATH AND THAT'S WHEN THE SURGEON FOUND OUT THAT THE CORE OF THE WIRE WAS SNAPPED AND ONLY THE COILS WERE SEEN COMING OUT OF THE SHEATH. SO THEY HAD TO SEND THE PATIENT TO A DIFFERENT DEPARTMENT, (B)(4) LAB, WHO TRIED TO SNARE THE DAMAGED WIRE. HE WAS ABLE TO PULL THE COIL WIRE OUT OF THE PATIENT. THE PATIENT HAD TO BE KEPT OVERNIGHT BECAUSE OF THIS." IT HAS BEEN INDICATED THAT THE USED GUIDEWIRE WILL BE RETURNED FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5662513 ↗
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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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