CoyoteRecalls & reported problems across all models
Boston Scientific Corporation · 55 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Coyote model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,085
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 1
We found 55 models of Coyote by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,085 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2017 and Jul 20, 2026 — classified as 30 injuries, 1,055 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (917 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Coyote recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 3, 2025Open, Classified
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
Z-1042-2026 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗
Most reported Coyote problems
Device problems
- Material Rupture917
- Entrapment of Device65
- Failure to Deflate22
- Break19
- Difficult to Advance19
- Deflation Problem16
- Leak/Splash16
- Difficult to Remove14
Patient problems
- No Clinical Signs, Symptoms or Conditions744
- No Consequences Or Impact To Patient318
- Foreign Body In Patient6
- No Known Impact Or Consequence To Patient6
- No Patient Involvement6
- Insufficient Information2
- Obstruction/Occlusion2
- Pain2
Coyote models
55 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Coyote™ H74939185202210Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ H74939185252210CATHETER, PERCUTANEOUS118 reports
- Coyote™ H74939185201510CATHETER, PERCUTANEOUS108 reports
- Coyote™ H74939185402210CATHETER, PERCUTANEOUS82 reports
- Coyote™ H74939185302210Catheter, angioplasty, peripheral, transluminal77 reports
- Coyote™ H74939185301510Catheter, angioplasty, peripheral, transluminal69 reports
- Coyote™ H74939185401510CATHETER, PERCUTANEOUS59 reports
- Coyote™ H74939186251210CATHETER, PERCUTANEOUS1 recall4 reports
- Coyote™ H74939186351210CATHETER, PERCUTANEOUS1 recall0 reports
- Coyote™ H74939186252210CATHETER, PERCUTANEOUS37 reports
- Coyote™ H74939185251510Catheter, angioplasty, peripheral, transluminal37 reports
- Coyote™ H74939186202210CATHETER, PERCUTANEOUS35 reports
- Coyote™ H74939186301510CATHETER, PERCUTANEOUS33 reports
- Coyote™ H74939186302210CATHETER, PERCUTANEOUS21 reports
- Coyote™ H74939186201510CATHETER, PERCUTANEOUS18 reports
- Coyote™ H74939185150410CATHETER, PERCUTANEOUS17 reports
- Coyote™ H74939186150410CATHETER, PERCUTANEOUS15 reports
- Coyote™ H74939186251510CATHETER, PERCUTANEOUS15 reports
- Coyote™ H74939186301010CATHETER, PERCUTANEOUS11 reports
- Coyote™ H74939186401510CATHETER, PERCUTANEOUS11 reports
- Coyote™ H74939186402210CATHETER, PERCUTANEOUS11 reports
- Coyote™ H74939186200610CATHETER, PERCUTANEOUS11 reports
- Coyote™ H74939185401010Catheter, angioplasty, peripheral, transluminal11 reports
- Coyote™ H74939186250810CATHETER, PERCUTANEOUS10 reports
- Coyote™ H74939186201010CATHETER, PERCUTANEOUS8 reports
- Coyote™ H74939186200810CATHETER, PERCUTANEOUS7 reports
- Coyote™ H74939185201010CATHETER, PERCUTANEOUS7 reports
- Coyote™ H74939186300810CATHETER, PERCUTANEOUS5 reports
- Coyote™ H74939186251010CATHETER, PERCUTANEOUS4 reports
- Coyote™ H74939186301210CATHETER, PERCUTANEOUS4 reports
- Coyote™ H74939186201210CATHETER, PERCUTANEOUS4 reports
- Coyote™ H74939186352210CATHETER, PERCUTANEOUS4 reports
- Coyote™ H74939186401010CATHETER, PERCUTANEOUS4 reports
- Coyote™ H74939186150490CATHETER, PERCUTANEOUS3 reports
- Coyote™ H74939185400610Catheter, angioplasty, peripheral, transluminal2 reports
- Coyote™ H74939185250810CATHETER, PERCUTANEOUS2 reports
- Coyote™ H74939186300610CATHETER, PERCUTANEOUS2 reports
- Coyote™ H74939186300690CATHETER, PERCUTANEOUS2 reports
- Coyote™ H74939185200610CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939185200810Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ H74939185300610Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ H74939186200890CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186201290CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186251090CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186350810CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186350890CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186400610CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186400810CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186351510CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939185251010Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ H74939185300810Catheter, angioplasty, peripheral, transluminal1 report
- Coyote™ H74939186251290CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186301590CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186350610CATHETER, PERCUTANEOUS1 report
- Coyote™ H74939186401210CATHETER, PERCUTANEOUS1 report
Recent Coyote adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING ENDOVASCULAR TREATMENT (EVT) OF A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE PERIPHERAL VASCULATURE, A 2.0 MM X 40 MM COYOTE BALLOON CATHETER WAS ADVANCED FOLLOWING GUIDEWIRE PASSAGE. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED DUE TO THE HIGHLY CALCIFIED LESION. DILATATION WAS CONTINUED USING A HIGH-PRESSURE BALLOON OF THE SAME SIZE, FOLLOWED BY A 2.5 MM X 150 MM COYOTE BALLOON CATHETER. HOWEVER, 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 25874047 ↗MalfunctionMay 27, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT HUB LEAK WAS NOTED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE BALLOON WAS INFLATED TO THE NOMINAL PRESSURE, THE BALLOON WAS LEAKING AT THE HUB. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE AND KINK 7.5CM FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300406 ↗MalfunctionApr 20, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 30 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 24921577 ↗MalfunctionApr 15, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885635 ↗MalfunctionApr 14, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 14 ATMOSPHERES FOR 30 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 24879499 ↗MalfunctionApr 8, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 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 24821505 ↗MalfunctionApr 6, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF BELOW THE KNEE. A 2.0MM X 120MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE SECOND INFLATION AT 4 ATMOSPHERES FOR ABOUT A MINUTE, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788744 ↗MalfunctionApr 6, 2026Inflation Problem; Material Rupture
IT WAS REPORTED THAT BALLOON PINHOLE WAS NOTED. THE 40% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.0MM X 100MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON DID NOT INFLATE, AND A BALLOON PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788740 ↗MalfunctionApr 2, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF BELOW THE KNEE. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO HEALTH INJURY OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24763912 ↗MalfunctionApr 2, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 3 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, 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 24762736 ↗MalfunctionApr 2, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24762194 ↗MalfunctionMar 30, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BELOW-THE-KNEE ARTERIES. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 24727972 ↗MalfunctionMar 10, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 60 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 24558860 ↗MalfunctionMar 8, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. DURING THE PROCEDURE, WIRING WAS ATTEMPTED USING A JUPITER FC GUIDEWIRE; HOWEVER, AFTER PROLONGED MANIPULATION, THE DISTAL TIP BECAME DEFORMED. THE DEVICE WAS REPLACED WITH A NEW JUPITER FC GUIDEWIRE, WHICH SUCCESSFULLY CROSSED THE LESION. SUBSEQUENTLY, DILATION WAS PERFORMED USING A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 7 ATMOSPHERES. THE DEVICE WAS THEN REPLACED WITH A NEW 2.0/150 COYOTE BALLOON CATHETER, AND DILATION WAS REATTEMPTED, FOLLOWED BY UPSIZING TO A 3 MM BALLOON. REVASCULARIZATION WAS SUCCESSFULLY ACHIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541752 ↗MalfunctionMar 3, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT NOMINAL PRESSURE FOR 3 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 24503128 ↗
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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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