PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP 9185JRecalls & reported problems
Volcarica S.R.L. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845225001117), received between Nov 24, 2018 and Nov 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K111395); they may or may not involve this specific model.
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 Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2018Material Separation; Material Separation
THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED THAT DURING PROCEDURE ERROR CODE "ATTACH WIRE TO CONNECTOR" WAS RECEIVED. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND DAMAGE WAS OBSERVED. THE PRESSURE SENSOR WAS BROKEN AND THE DISTAL PORTION WAS MISSING. THE WIRE WAS NOT RECOGNIZED DURING ZERO TESTING. THE PROBABLE CAUSE OF THE REPORTED FAILURE IS AN ELECTRICAL FAILURE WITH THE WIRE. THE DEVICE WAS OBSERVED TO HAVE A BROKEN SENSOR, WHICH IS CONSISTENT WITH THE REPORTED FAILURE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE A PORTION OF THE SENSOR IS MISSING FROM THE DEVICE, IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100314 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111395. One submission often covers many models, so check the product and lot details in each record.
- Z-1845-2015 · Jun 4, 2015 · TerminatedPrestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and periphe
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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