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R2P METACROSS RX BD-P30200ERRecalls & reported problems

Kaneka Corporation · R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). · 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 04540778167070), received between Jan 22, 2021 and Jan 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (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

  • Device Handling Problem1
  • Material Separation1
  • Use of Device Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 22, 2021Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem

    DR. (B)(6) WAS PERFORMING A LEFT ANTERIOR TIBIAL INTERVENTION ON THE PATIENT WHEN, AT THE END OF THE CASE, HE HAD AN ISSUE WITH THE R2P METACROSS 3X200 BALLOON INVOLVED IN THIS COMPLAINT. I WAS NOT PRESENT FOR THE CASE BUT FROM MY PHONE CONVERSATION ON YESTERDAY MORNING WITH DR. SWAMY, THE CASE WAS AS FOLLOWS. DR. (B)(6) WAS ABLE TO GET ACCESS VIA THE RIGHT FEMORAL WITH A PINNACLE SHEATH, THEN IN AN UP & OVER FASHION, A 6X45 PINNACLE DESTINATION WAS ADVANCED INTO THE LEFT CFA. AN INTERVENTION OF THE LEFT AT WAS THEN COMPLETED WITH A CSI DIAMONDBACK ATHERECTOMY DEVICE OVER A VIPER WIRE. THEN, OVER THE VIPER WIRE, A 150CM SHAFT LENGTH CROSPERIO BALLOON (SIZE UNKNOWN) WAS ADVANCED TO BALLOON THE AT BUT DR. SWAMY WAS NOT ABLE TO REACH THE TARGET AREA DUE TO SHAFT LENGTH. HE THEN ASKED FOR THE 3X200 R2P METACROSS WITH THE 200CM SHAFT LENGTH IN ORDER TO REACH THE TARGET AREA. UPON ADVANCING THIS BALLOON, HE MET RESISTANCE IN THE ILIAC AREA. NOT BEING ABLE TO ADVANCE THE BALLOON PAST THIS POINT, IT WAS DECIDED TO JUST FINISH THE CASE WITHOUT THIS LAST BALLOON INFLATION ATTEMPT. HE THEN ATTEMPTED TO REMOVE THE METACROSS BUT A GREAT DEAL OF RESISTANCE WAS ENCOUNTERED. WITH FURTHER ATTEMPTS,

    Patient problems: Foreign Body In Patient

    MAUDE report 11213088 ↗

Other Catheter, Angioplasty, Peripheral, Transluminal devices

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Sources and updates

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