MUSTANGRecalls & reported problems across all models
Boston Scientific Corporation · 131 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,644
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls
- 0
We found 131 models of MUSTANG by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 3,644 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Sep 24, 2026 — classified as 101 injuries, 3,543 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3,257 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 MUSTANG problems
Device problems
- Material Rupture3,257
- Leak/Splash120
- Inflation Problem99
- Adverse Event Without Identified Device or Use Problem97
- Difficult to Remove77
- Detachment of Device or Device Component54
- Entrapment of Device53
- Break37
Patient problems
- No Clinical Signs, Symptoms or Conditions2,507
- No Consequences Or Impact To Patient1,088
- No Known Impact Or Consequence To Patient18
- Foreign Body In Patient15
- No Patient Involvement13
- No Code Available7
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
MUSTANG models
131 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- MUSTANG™ H74939171060470CATHETER, BILIARY, DIAGNOSTIC384 reports
- MUSTANG™ H74939171070470CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470CATHETER, BILIARY, DIAGNOSTIC212 reports
- MUSTANG™ H74939171100470CATHETER, BILIARY, DIAGNOSTIC203 reports
- MUSTANG™ H74939171060440CATHETER, BILIARY, DIAGNOSTIC202 reports
- MUSTANG™ H74939171061070CATHETER, BILIARY, DIAGNOSTIC187 reports
- MUSTANG™ H74939171080470CATHETER, BILIARY, DIAGNOSTIC170 reports
- MUSTANG™ H74939171050440CATHETER, BILIARY, DIAGNOSTIC169 reports
- MUSTANG™ H74939171120470CATHETER, BILIARY, DIAGNOSTIC102 reports
- MUSTANG™ H74939171060410CATHETER, BILIARY, DIAGNOSTIC95 reports
- MUSTANG™ H74939171040470CATHETER, BILIARY, DIAGNOSTIC90 reports
- MUSTANG™ H74939171090470CATHETER, BILIARY, DIAGNOSTIC73 reports
- MUSTANG™ H74939171071070CATHETER, BILIARY, DIAGNOSTIC70 reports
- MUSTANG™ H74939171051070CATHETER, BILIARY, DIAGNOSTIC59 reports
- MUSTANG™ H74939171040440CATHETER, BILIARY, DIAGNOSTIC54 reports
- MUSTANG™ H74939171080410CATHETER, BILIARY, DIAGNOSTIC50 reports
- MUSTANG™ H74939171050410CATHETER, BILIARY, DIAGNOSTIC47 reports
- MUSTANG™ H74939171070440CATHETER, BILIARY, DIAGNOSTIC44 reports
- MUSTANG™ H74939171070410CATHETER, BILIARY, DIAGNOSTIC43 reports
- MUSTANG™ H74939171060870CATHETER, BILIARY, DIAGNOSTIC43 reports
- MUSTANG™ H74939171060670CATHETER, BILIARY, DIAGNOSTIC40 reports
- MUSTANG™ H74939171100270CATHETER, BILIARY, DIAGNOSTIC39 reports
- MUSTANG™ H74939171061010CATHETER, BILIARY, DIAGNOSTIC34 reports
- MUSTANG™ H74939171040410CATHETER, BILIARY, DIAGNOSTIC33 reports
- MUSTANG™ H74939171061510Catheter, angioplasty, peripheral, transluminal31 reports
- MUSTANG™ H74939171062010Catheter, angioplasty, peripheral, transluminal30 reports
- MUSTANG™ H74939171070870CATHETER, BILIARY, DIAGNOSTIC29 reports
- MUSTANG™ H74939171120670CATHETER, BILIARY, DIAGNOSTIC28 reports
- MUSTANG™ H74939171070670CATHETER, BILIARY, DIAGNOSTIC26 reports
- MUSTANG™ H74939171100410CATHETER, BILIARY, DIAGNOSTIC25 reports
- MUSTANG™ H74939171070270CATHETER, BILIARY, DIAGNOSTIC24 reports
- MUSTANG™ H74939171090270CATHETER, BILIARY, DIAGNOSTIC24 reports
- MUSTANG™ H74939171062070Catheter, angioplasty, peripheral, transluminal23 reports
- MUSTANG™ H74939171060270CATHETER, BILIARY, DIAGNOSTIC22 reports
- MUSTANG™ H74939171051510Catheter, angioplasty, peripheral, transluminal22 reports
- MUSTANG™ H74939171120410CATHETER, BILIARY, DIAGNOSTIC22 reports
- MUSTANG™ H74939171051010CATHETER, BILIARY, DIAGNOSTIC21 reports
- MUSTANG™ H74939171120810CATHETER, BILIARY, DIAGNOSTIC21 reports
- MUSTANG™ H74939171080270CATHETER, BILIARY, DIAGNOSTIC20 reports
- MUSTANG™ H74939171071010CATHETER, BILIARY, DIAGNOSTIC20 reports
- MUSTANG™ H74939171041070CATHETER, BILIARY, DIAGNOSTIC18 reports
- MUSTANG™ H74939171080670CATHETER, BILIARY, DIAGNOSTIC17 reports
- MUSTANG™ H74939171120870CATHETER, BILIARY, DIAGNOSTIC17 reports
- MUSTANG™ H74939171061570Catheter, angioplasty, peripheral, transluminal16 reports
- MUSTANG™ H74939171100810CATHETER, BILIARY, DIAGNOSTIC16 reports
- MUSTANG™ H74939171052010Catheter, angioplasty, peripheral, transluminal15 reports
- MUSTANG™ H74939171040270CATHETER, BILIARY, DIAGNOSTIC15 reports
- MUSTANG™ H74939171081070CATHETER, BILIARY, DIAGNOSTIC15 reports
- MUSTANG™ H74939171060810CATHETER, BILIARY, DIAGNOSTIC15 reports
- MUSTANG™ H74939171100670CATHETER, BILIARY, DIAGNOSTIC15 reports
- MUSTANG™ H74939171050270CATHETER, BILIARY, DIAGNOSTIC14 reports
- MUSTANG™ H74939171080440CATHETER, BILIARY, DIAGNOSTIC14 reports
- MUSTANG™ H74939171120270CATHETER, BILIARY, DIAGNOSTIC14 reports
- MUSTANG™ H74939171041510Catheter, angioplasty, peripheral, transluminal13 reports
- MUSTANG™ H74939171060610CATHETER, BILIARY, DIAGNOSTIC13 reports
- MUSTANG™ H74939171072070Catheter, angioplasty, peripheral, transluminal13 reports
- MUSTANG™ H74939171120610CATHETER, BILIARY, DIAGNOSTIC12 reports
- MUSTANG™ H74939171080870CATHETER, BILIARY, DIAGNOSTIC11 reports
- MUSTANG™ H74939171030470CATHETER, BILIARY, DIAGNOSTIC11 reports
- MUSTANG™ H74939171090870CATHETER, BILIARY, DIAGNOSTIC11 reports
- MUSTANG™ H74939171100610CATHETER, BILIARY, DIAGNOSTIC11 reports
- MUSTANG™ H74939171050870CATHETER, BILIARY, DIAGNOSTIC10 reports
- MUSTANG™ H74939171100870CATHETER, BILIARY, DIAGNOSTIC10 reports
- MUSTANG™ H74939171041010CATHETER, BILIARY, DIAGNOSTIC9 reports
- MUSTANG™ H74939171040870CATHETER, BILIARY, DIAGNOSTIC9 reports
- MUSTANG™ H74939171071570Catheter, angioplasty, peripheral, transluminal9 reports
- MUSTANG™ H74939171060240CATHETER, BILIARY, DIAGNOSTIC8 reports
- MUSTANG™ H74939171050670CATHETER, BILIARY, DIAGNOSTIC8 reports
- MUSTANG™ H74939171040670CATHETER, BILIARY, DIAGNOSTIC7 reports
- MUSTANG™ H74939171071270CATHETER, BILIARY, DIAGNOSTIC7 reports
- MUSTANG™ H74939171060210CATHETER, BILIARY, DIAGNOSTIC6 reports
- MUSTANG™ H74939171051570Catheter, angioplasty, peripheral, transluminal6 reports
- MUSTANG™ H74939171090410CATHETER, BILIARY, DIAGNOSTIC6 reports
- MUSTANG™ H74939171052070Catheter, angioplasty, peripheral, transluminal6 reports
- MUSTANG™ H74939171031510Catheter, angioplasty, peripheral, transluminal6 reports
- MUSTANG™ H74939171061210CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171042010Catheter, angioplasty, peripheral, transluminal5 reports
- MUSTANG™ H74939171080210CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171050240CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171040240CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171081010CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171080810CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171120210CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171080610CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171060640CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171050640CATHETER, BILIARY, DIAGNOSTIC5 reports
- MUSTANG™ H74939171050210CATHETER, BILIARY, DIAGNOSTIC4 reports
- MUSTANG™ H74939171040210CATHETER, BILIARY, DIAGNOSTIC4 reports
- MUSTANG™ H74939171071510Catheter, angioplasty, peripheral, transluminal4 reports
- MUSTANG™ H74939171100210CATHETER, BILIARY, DIAGNOSTIC4 reports
- MUSTANG™ H74939171040610CATHETER, BILIARY, DIAGNOSTIC4 reports
- MUSTANG™ H74939171031010CATHETER, BILIARY, DIAGNOSTIC4 reports
- MUSTANG™ H74939171051210CATHETER, BILIARY, DIAGNOSTIC3 reports
- MUSTANG™ H74939171050810CATHETER, BILIARY, DIAGNOSTIC3 reports
- MUSTANG™ H74939171072010Catheter, angioplasty, peripheral, transluminal3 reports
- MUSTANG™ H74939171070810CATHETER, BILIARY, DIAGNOSTIC3 reports
- MUSTANG™ H74939171070610CATHETER, BILIARY, DIAGNOSTIC3 reports
- MUSTANG™ H74939171070640CATHETER, BILIARY, DIAGNOSTIC3 reports
- MUSTANG™ H74939171031210CATHETER, BILIARY, DIAGNOSTIC2 reports
- MUSTANG™ H74939171050610CATHETER, BILIARY, DIAGNOSTIC2 reports
Recent MUSTANG adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889969 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Material Rupture
It was reported that balloon leak and rupture occurred.The more than 90% stenosed target lesion was located in the left superficial femoral artery. A 10.0 x 80, 135cm MUSTANG balloon catheter was advanced for dilation. During inflation at 12 atmospheres, the balloon was noted to have an irregular configuration, failing to achieve the desired dilatation effect, and contrast extravasation was visible from the site of balloon rupture. The balloon was fully deflated, and the ruptured balloon catheter was safely withdrawn along with the guidewire. The procedure was completed with another of the same device. There were no patient complications as a result of this event. The patient remained stable following the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842870 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel. A 6.0 x 40, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation. The device was removed without any problem using the normal method, and the procedure was completed with another of the same 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 50839501 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified external Iliac artery. A 7.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured and in a pinhole form at the middle part upon first inflation at 8 atmospheres for 3 seconds. The device was removed without any problem using the normal method, 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 50839487 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon burst occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified arteriovenous (AV) shunt. A 10.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon burst at 12 atmospheres before inflating to the Nominal Burst Pressure (NBP). The procedure was completed with another of same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838950 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified veins in the left forearm. A 5.0 x 40, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at nominal pressure atmospheres for 30 seconds. The device was removed without any problem using the normal method, and the procedure was completed with another of same 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 50838899 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon burst occurred.A 6.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the pressure was within the normal range, but the balloon burst. The procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836669 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified Iliac artery. A 4.0 x 40, 135cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 20 atmospheres for 30 seconds. The device was removed without any problem using the normal method, 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 50836665 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon burst occurred.The stenosed target lesion was located in the arteriovenous fistula. A 6.0 x 60, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, it was noted that the balloon burst. The procedure was completed with another of same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836660 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel. A 10.0 x 60, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured at 8 atmospheres. 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 50836565 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified subclavian vein. A 12.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon vertically ruptured from the tip to the middle upon first inflation at 8 atmospheres for 30 seconds. The device was removed only using normal method without any problem, and the procedure was completed with another of the same 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 50836564 ↗MalfunctionSep 21, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem
Reportable based on device analysis completed on (b)(6)2026.It was reported that balloon advancing issue occurred.The 50-60% stenosed target lesion was located in the severely tortuous and mildly calcified arteriovenous fistula. A 6.0 x 200, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon was fully deflated prior to advancement. However, significant resistance was encountered while advancing the catheter through the sheath. The procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient's condition post-procedure was stable.However, device analysis revealed a complete circumferential tear located at approximately 53mm distal of the proximal sleeve. A separation of the shaft was located at approximately at the same location of the complete circumferential tear, and the proximal markerband was found to be damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836563 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and non-calcified cephalic vein. A 6.0 x 60, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 10 atmospheres. The device was removed without any problem using the normal method, 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 50836560 ↗MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified limb. A 4.0 x 150, 135cm Mustang balloon catheter was selected for below the knee angioplasty. During the procedure, the balloon ruptured upon first inflation at 24 atmospheres for 2 minutes. The balloon was removed successfully from the patient, and the procedure was completed with a 4x100 Mustang. There were no patient complications as a result of this event, and the patient was stable post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835897 ↗MalfunctionSep 18, 2026Material Rupture
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified shunt. A 6.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 10 atmospheres for 2 seconds. The device was removed without any problem using the normal method, 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 50821780 ↗
Other Boston Scientific Corporation products
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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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