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R2P METACROSS RX BD-P50040ERRecalls & 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 04540778166455), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

  • Deformation Due to Compressive Stress1
  • Material Twisted/Bent1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • 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.

  • InjuryJul 29, 2021Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

    LEFT RADIAL ACCESS, 6FR 10CM SLENDER, USED GWA TRACK 018, PRE-DILATED FOCAL PROXIMAL SFA LESION (90%) WITH CROSSTELLA 2X40X200, THEN USED ANGIOSCULPT 5X20X137,THEN EXCHANGED FOR GWA 35 260CM, SUCCESSFULLY DELIVERED A MISAGO 6X40X200, ATTEMPTED TO POST DILATE WITH ABBOTT VASCULAR ARMADA 5X40X135 (NOT SUCCESSFUL, WOULD ADVANCE INTO 1/3 OF THE STENT BUT NO FURTHER), ATTEMPTED TO POST DILATE WITH R2P METACROSS 5X40X200 AND NOTICED THAT WHILE IN THE DESCENDING AORTA, THE BALLOON STOPPED ADVANCING. PHYSICIAN STOPPED AND WENT TO LOOK. CATHETER WAS VISIBLY LOOPED AND THE PHYSICIAN TRIED TO ADVANCE AND PULL BACK TO UNLOOP THE CATHETER. UNSUCCESSFUL. HE THEN TRIED TO REMOVE THE SYSTEM (WIRE, BALLOON AND SHEATH) BUT THE BALLOON SYSTEM STARTED CAUSING PATIENT DISCOMFORT AND RESISTANCE WAS OBSERVED. EVERYTHING WAS LEFT IN AND THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE UNIVERSITY OF IOWA FOR VASCULAR SURGERY INTERVENTION. A RADIAL CUTDOWN WAS PERFORMED BELOW THE ELBOW AND THE SYSTEM WAS REMOVED IN SECTIONS BY USING A WIRE CUTTER. THE BALLOON SYSTEM WAS INTACT BUT THE CATHETER HAD KINKED AND WAS NOT ABLE TO STRAIGHTEN TO REMOVE. THE PATIENT RECEIVED ONE UNIT OF BLOOD AND A XENOSURE BIOLOGIC

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 12244571 ↗

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Sources and updates

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