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CROSSTELLA OTW BD-F50200LWRecalls & reported problems

Kaneka Corporation · CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm). · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778162334), received between Aug 2, 2018 and Apr 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 Separation2
  • Device Handling Problem1
  • Use of Device Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 8, 2019Material Separation; Material Separation

    IN-STENT RESTENOSIS LESION IN LEFT SFA. THE CATHETER WAS APPROACHED TO THE LESION USING DESTINATION SHEATH FROM THE RIGHT FEMORAL ARTERY. WHEN THE BALLOON WAS DILATED AT 12 ATM AT THE LESION, IT WAS RUPTURED AND COULD NOT BE REMOVED. THE OPERATOR TRIED TO PULL THE BALLOON INTO THE SHEATH AFTER BRINGING THE DISTAL TIP OF THE SHEATH AS CLOSE TO THE BALLOON AS POSSIBLE, BUT THE OPERATOR COULDN'T DO IT. AFTER THAT, THE 6 FR SHEATH WAS REPLACED WITH 8FR AND IT WAS ATTEMPTED TO WITHDRAW THE BALLOON WITH SNARE, BUT IT COULD NOT BE DONE. FINALLY, WHILE THE CATHETER WAS CONTINUOUSLY PULLED OUT, THE BALLOON WAS BROKEN NEAR THE PUNCTURED PART.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8494202 ↗
  • InjuryAug 2, 2018Material Separation; Use of Device Problem; Device Handling Problem; Material Separation; Use of Device Problem; Device Handling Problem

    CROSSOVER ACCESS 7F DESTINATION, OCCLUSION DISTAL AFS TO SEGMENT P1, RECANALIZATION WITH GWA 18, VERY HEAVILY CALCIFIED VASCULAR SEGMENT, SUBSEQUENT DILATATION OF THE RECANALIZED AREA WITH THE BALLOON, THEREBY BURSTING OF THE BALLOON. UPON WITHDRAWAL, IT IS NOTED THAT THERE IS A DETACH OF THE 20 CM LONG BALLOON (ABOUT 5 CM DISTAL) AND REMAIN IN THE PATIENT. SUBSEQUENTLY, SUCCESSFUL RECANALIZATION OF THE REMAINING BALLOON SEGMENT AND OVERSTENTING WITH A SUPERA.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7742799 ↗

Other Catheter, Angioplasty, Peripheral, Transluminal devices

All Catheter, Angioplasty, Peripheral, Transluminal devices →

Sources and updates

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