Verrata Pressure Guide Wire 300cm 10300Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845225002459), received between May 2, 2018 and May 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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 Separation1
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 2, 2018Material Separation; Material Separation
THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THIS SUPPLEMENTAL REPORT (#2) IS BEING SUBMITTED TO CORRECT AN ENTRY ERROR IN THE DEVICE ANALYSIS PROVIDED IN SUPPLEMENTAL REPORT #1.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7481661 ↗
Other Transducer, Pressure, Catheter Tip devices
- TRUWAVE PX260Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall29 reports
- TRUWAVE, VAMP PLUS PXVP2284AT3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall9 reports
- TruWave, VAMP T001744MEdwards Lifesciences LLC · Transducer, Pressure, Catheter Tip1 recall6 reports
- Comet H7493932430Boston Scientific Corporation · TRANSDUCER, PRESSURE, CATHETER TIP56 reports
- TRUWAVE PXMK2041Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall4 reports
- TRUWAVE PX284Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall3 reports
- TRUWAVE, VAMP PLUS PXVP2260Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP23X3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 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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