Coyote ESRecalls & reported problems across all models
Boston Scientific Corporation · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,560
- Deaths reported
- 1
- Injuries reported
- 48
- Recalls
- 0
We found 26 models of Coyote ES by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 3,560 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Aug 18, 2026 — classified as 1 death, 48 injuries, 3,511 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3,388 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Coyote ES problems
Device problems
- Material Rupture3,388
- Failure to Advance51
- Entrapment of Device44
- Adverse Event Without Identified Device or Use Problem38
- Break38
- Difficult to Remove31
- Detachment of Device or Device Component30
- Material Deformation22
Patient problems
- No Clinical Signs, Symptoms or Conditions2,501
- No Consequences Or Impact To Patient1,043
- Foreign Body In Patient8
- No Patient Involvement6
- No Known Impact Or Consequence To Patient4
- No Code Available3
- Device Embedded In Tissue or Plaque1
- Hematoma1
Coyote ES models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Coyote™ ES H74939135152010Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ ES H74939135254010Catheter, angioplasty, peripheral, transluminal127 reports
- Coyote™ ES H74939135302010Catheter, angioplasty, peripheral, transluminal1 death117 reports
- Coyote™ ES H74939134204010Catheter, angioplasty, peripheral, transluminal110 reports
- Coyote™ ES H74939135402010Catheter, angioplasty, peripheral, transluminal107 reports
- Coyote™ ES H74939134202010Catheter, angioplasty, peripheral, transluminal71 reports
- Coyote™ ES H74939135252010Catheter, angioplasty, peripheral, transluminal64 reports
- Coyote™ ES H74939134304010Catheter, angioplasty, peripheral, transluminal46 reports
- Coyote™ ES H74939134254010Catheter, angioplasty, peripheral, transluminal24 reports
- Coyote™ ES H74939134302010Catheter, angioplasty, peripheral, transluminal16 reports
- Coyote™ ES H74939134252010Catheter, angioplasty, peripheral, transluminal6 reports
- Coyote™ ES H74939134404010Catheter, angioplasty, peripheral, transluminal5 reports
- Coyote™ ES H74939134354010Catheter, angioplasty, peripheral, transluminal2 reports
- Coyote™ ES H74939135203010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939135253010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939135303010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939135353010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939135354010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939134203010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939134352010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ ES H74939134402010Catheter, angioplasty, peripheral, transluminal1 report
Recent Coyote ES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302866 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278479 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278475 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278447 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left popliteal artery. A 2mm x 40mm x 145cm Coyote ES MR balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 12 atmospheres for 10 seconds. The device was removed without any problem, and the procedure was completed with a different device. There were no patient complications as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50274613 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50273299 ↗MalfunctionAug 17, 2026Inflation Problem; Material Rupture; Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50270997 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50270989 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified pulmonary artery. A 2mm x 20mm x 143cm Coyote ES balloon catheter was advanced for dilatation. The balloon was inflated multiple times at 10, 12, and 14 atmospheres for 30 seconds each; however, during the third inflation at 14 atmospheres, the balloon ruptured with a pinhole rupture. The rupture location could not be confirmed because the device was discarded. The balloon was removed using the normal method without difficulty, and another Coyote ES was used for further inflation. The procedure was completed successfully using different types of balloons. No patient complications were reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50270987 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209665 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205079 ↗MalfunctionAug 7, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174707 ↗MalfunctionJul 20, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING ENDOVASCULAR TREATMENT (EVT) OF A CHRONIC TOTAL OCCLUSION (CTO) LESION, A 2.0 MM X 40 MM COYOTE BALLOON CATHETER WAS ADVANCED FOLLOWING GUIDEWIRE PASSAGE. HOWEVER, DUE TO THE HIGHLY CALCIFIED LESION, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. DILATATION WAS CONTINUED USING A HIGH-PRESSURE (HP) BALLOON OF THE SAME SIZE, FOLLOWED BY A 2.5 MM X 150 MM COYOTE BALLOON CATHETER. DURING THE SECOND INFLATION AT 6 ATMOSPHERES, THE SECOND COYOTE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED USING A HIGH-PRESSURE BALLOON OF THE SAME SIZE FOLLOWED BY POST-DILATATION WITH A 3 MM HIGH-PRESSURE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874044 ↗MalfunctionJul 13, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25793166 ↗MalfunctionJun 29, 2026Difficult to Remove; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURED AND REMOVAL DIFFICULTY OCCURRED. A 3MM X 40MM X 146CM COYOTE ES WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED IN A CALCIFIED ARTERY. DURING REMOVAL, PART OF THE SHEATH REMAINED CAUGHT ON THE GUIDEWIRE AND THE TIP OF THE BALLOON REMAINED ATTACHED TO THE GUIDEWIRE. IMMEDIATE ACTION WAS PERFORMED BY REMOVING THE GUIDEWIRE FROM THE PATIENT. IT WAS NOTED THAT THE PROCEDURE WAS INTERRUPTED. THERE WERE MINOR CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25654049 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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