Coyote™ H74939186400610Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Coyote (55)
Data updated Oct 16, 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 08714729796633), received between Nov 8, 2023 and Nov 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deflate” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deflate1
- Leak/Splash1
- 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.
MalfunctionNov 8, 2023Leak/Splash; Material Rupture; Failure to Deflate; Leak/Splash; Material Rupture; Failure to Deflate
IT WAS REPORTED THAT THE COYOTE BALLOON LEAKED AND WAS UNABLE TO BE DEFLATED. A COYOTE, 4.0MM X 60MM X 150CM, OTW WAS SELECTED FOR USE TO TREAT A CASE OF IN-STENT RESTENOSIS IN THE RIGHT LOWER EXTREMITY. THE TARGET LESION WAS SEVERELY CALCIFIED AND MODERATELY TORTUOUS WITH 100% STENOSIS. THE FIRST COYOTE BALLOON TRACKED WELL OVER THE UNKNOWN 6FR PEDAL SHEATH. A RANGER BALLOON WAS UNABLE TO TRACK OVER THE SHEATH, AND WAS REPLACED WITH A STERLING BALLOON, WHICH TRACKED REASONABLY WELL. THE SECOND COYOTE BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED, AND IT WAS OBSERVED THAT THE BALLOON WAS LEAKING. THE COYOTE BALLOON WAS UNABLE TO BE DEFLATED, AND THE ENTIRE SYSTEM WAS PULLED FROM THE PEDAL ACCESS. THE PROCEDURE WAS CANCELLED, AS THE IN-STENT STENOSIS WAS DEEMED TO BE TOO EXTENSIVE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE SECOND COYOTE BALLOON WAS INFLATED TO NOMINAL PRESSURE WHEN THE LEAK WAS OBSERVED. THE COYOTE BALLOON WAS REMOVED INTACT FROM THE PATIENT IN A SEMI-DEFLATED STATE OVER THE COURSE OF 10-15 SECONDS BY WALKING THE BALLOON OFF THE GUIDEWIRE. ONCE REMOVED FROM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093639 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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