Phoenix 1.5mm x 149cm 4F Atherectomy System P15149K (UDI 00845225003531)Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845225003531), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.
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.
MalfunctionSep 5, 2025Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY FIBROUS PROXIMAL POPLITEAL LESION. THE CATHETER WAS DELIVERED OVER A NON-PHILIPS GUIDEWIRE, AND ADVANCED TO THE LESION AND TURNED ON. AFTER LESS THAN A MINUTE, THE CATHETER WAS TURNED OFF AND ATTEMPTED TO REMOVE, BUT GOT STUCK ON THE GUIDEWIRE AND WAS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND CONCOMITANT DEVICE WERE REMOVED AS A SYSTEM; POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983914 ↗
Other Catheter, Peripheral, Atherectomy devices
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- JETSTREAM™ XC 112266-001Boston Scientific Corporation · Catheter, peripheral, atherectomy288 reports
- JETSTREAM™ XC 112264-001Boston Scientific Corporation · Catheter, peripheral, atherectomy262 reports
- SET Rotarex®S 6F 135cm (Straub Medical®) Version 1.0Straub Medical AG · Catheter, Peripheral, Atherectomy2 deaths206 reports
- SET Rotarex™S 6 F x 135 cm 80237Straub Medical AG · Catheter, Peripheral, Atherectomy1 recall79 reports
- HawkOne™ H1-SCovidien LP · Catheter, peripheral, atherectomy1 recall70 reports
- Turbo-Elite Laser Atherectomy Catheter 420-006Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls19 reports
- Turbo-Elite Laser Atherectomy Catheter 417-152Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls16 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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