R2P CROSSTELLA RX BD-Q50100ERRecalls & reported problems
Kaneka Corporation · R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm). · 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 04540778175396), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
InjuryApr 8, 2026Material Fragmentation
THE DEVICE WAS USED FOR PRE-DILATATION OF A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AFTER DILATATION OF THE TARGET LESION, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE DEVICE. WHILE CONTINUING THE WITHDRAWAL CAREFULLY, THE DEVICE WAS OBSERVED TO HAVE CAUGHT ON A PREVIOUSLY IMPLANTED STENT LOCATED IN THE COMMON ILIAC ARTERY, AND A SHAFT FRACTURE OF THE DEVICE WAS CONFIRMED. SUBSEQUENTLY, THE LEFT FEMORAL ARTERY WAS PUNCTURED AND A SNARE WAS USED TO RETRIEVE THE FRACTURED PORTION OF THE DEVICE. AFTER RETRIEVAL, NO INTRAVASCULAR RETAINED FRAGMENTS WERE OBSERVED. THE TARGET LESION WAS THEN TREATED USING A DRUG-COATED BALLOON, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 24824606 ↗
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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