Phoenix 2.4mm x 130cm 7F Pre-Deflected Atherectomy System PD24130KRecalls & 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 00845225003593), received between Jul 21, 2026 and Jul 21, 2026 — 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.
InjuryJul 21, 2026Entrapment of Device
IT WAS REPORTED THAT A PHOENIX ATHERECTOMY CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN THE MID SFA. DURING USE, THE CATHETER GOT CAUGHT ON A STENT STRUT AND UNABLE TO REMOVE THE CATHETER. AN ANGIOPLASTY BALLOON WAS ADVANCED JUST BELOW WHERE THE CATHETER WAS STUCK, AND THE STENT DISLODGED FROM THE CATHETER. THE CATHETER WAS WITHDRAWN FROM THE PATIENT WITH NO DAMAGE OBSERVED TO THE DEVICE OR THE STENT. THE PROCEDURE WAS FINALIZED WITH NO FURTHER COMPLICATIONS AND NO PATIENT INJURY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO ENTRAPMENT, REQUIRING INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25898702 ↗
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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