R2P METACROSS RX BD-P50060ERRecalls & 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 04540778166578), received between Feb 8, 2023 and Feb 8, 2023 — 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
- Fracture1
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.
InjuryFeb 8, 2023Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress
PROCEDURE WAS A PERIPHERAL INTERVENTION FROM RIGHT RADIAL. BALLOON GOT WRAPPED AROUND GUIDEWIRE AND GOT STUCK IN THE RADIAL ARTERY. THE BALLOON AND WIRE WERE ABLE TO BE REMOVED WITHOUT DAMAGING THE ARTERY BY PERFORMING A 2-3CM MINOR CUT DOWN IN FOREARM, AND SUTURE EVERYTHING CLOSED.
Patient problems: Foreign Body In Patient
MAUDE report 16326647 ↗
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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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