ProVia 9 9PROV300HSRecalls & reported problems
Medtronic, Inc. · GDWR 9PROV300HS ProVia 5pk 300 HY ST · 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 00643169453036), received between Feb 14, 2018 and Feb 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
A PRO VIA 9 GUIDEWIRE WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY . IT IS REPORTED THAT THE TIP BROKE OFF THE PRO VIA 9 GUIDE WIRE IN VIVO AND THE PHYSICIAN PINNED THE DETACHED PORTION OF THE WIRE AGAINST THE VESSEL WALL WITH A STENT. NO PATIENT INJURY IS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem
MAUDE report 7270718 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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