Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy Catheter PD22130Recalls & reported problems
Volcano Atheromed, Inc. · 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 00845225002985), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 malfunction.
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
- 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.
MalfunctionFeb 18, 2021Material Separation; Material Separation
THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURERS POLICY. IT WAS REPORTED AFTER A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, THE SHAFT OF THE DEVICE APPEARED TO HAVE A FORMED A SMALL RIP (FRACTURE), ALLOWING FLUID TO ESCAPE. THE DEVICE WAS REMOVED FROM THE BODY OVER THE WIRE, AFTER THE DEVICE SEEMED TO BIND UP AND STOP WORKING. ADDITIONAL INFORMATION PROVIDED, THE DEVICE HAD BEEN INSERTED INTO THE PATIENT ONCE. THERE WERE NO ISSUES BEING REMOVED. THE DEVICE WAS RE-FLUSHED AFTER REMOVAL AND SALINE/BLOOD WAS BEING EJECTED FROM THE SHAFT OF THE DEVICE. NOTHING APPEARED TO BE PROTRUDING. A SECOND OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED AT THE FACILITY AND NOT RETURNED FOR ANALYSIS. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION AS IT COULD NOT BE DETERMINED WHERE OR WHEN THE ALLEGED SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE ALLEGED SEPARATION WERE TO RECUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11346812 ↗
Other Catheter, Peripheral, Atherectomy devices
- HawkOne™ H1-MCovidien LP · Catheter, peripheral, atherectomy1 recall367 reports
- 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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