METACROSS RX BD-LX2040CRRecalls & reported problems
Kaneka Corporation · METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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 04540778152397), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Material Puncture/Hole1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2020Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation
AFTER PLACING A STENT (14 MM X 40 MM) IN AORTA CASE, USE THE METACROSS RX(12 MM X 40 MM) FOR POST-EXPANSION. THE DOCTOR TRIED TO REMOVE IT AFTER DEFLATION, BUT IT CAUGHT ON THE SHEATH AND COULD NOT BE REMOVED. AFTER THAT, THE SHAFT WAS CUT, THE SHEATH WAS REPLACED, AND THE PRODUCT WAS REMOVED BY A SURGICAL PROCEDURE.
Patient problems: Injury
MAUDE report 9645467 ↗
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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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