Reconnaissance PV .018 OTW Digital IVUS Catheter 018OTWRecalls & reported problems
Philips Image Guided Therapy Corporation · 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 00845225003067), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 2, 2023Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A RECONNAISSANCE CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED DISTAL SFA. DURING INSERTION OF THE CATHETER THROUGH AN INTRODUCER SHEATH AND OVER A NON-PHILIPS GUIDEWIRE, THE GUIDEWIRE GOT CAUGHT AND UNABLE TO EXIT OUT OF THE CATHETER GUIDEWIRE EXIT PORT (Y-CONNECTOR). THE CATHETER WAS REMOVED, RE-FLUSHED, AND REINSERTED INTO THE PATIENT, BUT DID NOT RESOLVE. THEREFORE, THE PHYSICIAN CUT OFF A PIECE OF THE Y-CONNECTOR IN ORDER TO ALLOW GUIDEWIRE MOVEMENT. AFTER, THE CATHETER WAS ABLE TO ADVANCE FURTHER DOWN THE GUIDEWIRE TOWARD THE STENOSIS. THERE WAS NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A NON-PHILIPS GUIDEWIRE GOT STUCK INSIDE THE RECONNAISSANCE CATHETER, AND ADDITIONAL INTERVENTION WAS REQUIRED FOR GUIDEWIRE MOVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17852702 ↗
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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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