R2P METACROSS RX BD-P80040ERRecalls & 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 04540778166516), received between Oct 29, 2020 and Oct 29, 2020 — 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 Rupture1
- 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.
InjuryOct 29, 2020Material Rupture; Material Separation; Use of Device Problem; Device Handling Problem; Material Rupture; Material Separation; Use of Device Problem; Device Handling Problem
DURING A FISTULOGRAM ANGIOPLASTY, YOU COULD SEE THE BALLOON NOT FULLY EXPAND EVEN AT BURST PRESSURE. THE BALLOON BURST. UPON REMOVAL IT WAS NOTED THAT THE BALLOON BURST CIRCUMFERENTIALLY VS LONGITUDINALLY AND PART OF THE BALLOON (NYLON) WAS LEFT IN THE ANEURYSMAL SECTION OF THE FISTULA. THE BALLOON CATHETER WAS REMOVED AND THE PATIENT ACCESS SITE CLOSED.
Patient problems: Foreign Body In Patient
MAUDE report 10753317 ↗
Other Catheter, Angioplasty, Peripheral, Transluminal devices
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- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 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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