CROSSTELLA RX BD-F25200LRRecalls & reported problems
Kaneka Corporation · CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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 04540778159396), received between Aug 7, 2018 and Aug 7, 2018 — 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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2018Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem
DR. REPORTS THE BALLOON RUPTURED DURING A CHALLENGING BALLOON ANGIOPLASTY. THERE WAS SIGNIFICANT CALCIFICATION PRESENT. THE BALLOON ITSELF REMAINED INSIDE THE ARTERY. HE PLACED A STENT AT THE SEGMENT OF THE ARTERY THAT HAD THE BALLOON MATERIAL PRESENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7757467 ↗
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- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
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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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