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Coyote™ H74939186251290Recalls & reported problems

Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2

All models of Coyote (55)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729797197), received between May 15, 2023 and May 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 15, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE BALLOON DID NOT HOLD PRESSURE AFTER INFLATION. A 2.5MM X 120MM X 90CM COYOTE BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING INFLATION, IT WAS OBSERVED THAT THE BALLOON WOULD NOT HOLD THE INFLATION PRESSURE. THE DEVICE WAS EXCHANGED FOR NEW DEVICE, SAME MODEL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, THE DEVICE EVALUATION REVEALED A PINHOLE IN THE BALLOON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16934304 ↗

Other CATHETER, PERCUTANEOUS devices

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Sources and updates

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