SterlingRecalls & reported problems across all models
Boston Scientific Corporation · 153 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,907
- Deaths reported
- 1
- Injuries reported
- 86
- Recalls
- 0
We found 153 models of Sterling by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,907 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2017 and Sep 30, 2026 — classified as 1 death, 86 injuries, 2,820 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2,614 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 Sterling problems
Device problems
- Material Rupture2,614
- Deflation Problem55
- Detachment of Device or Device Component49
- Difficult to Remove43
- Entrapment of Device41
- Adverse Event Without Identified Device or Use Problem40
- Break40
- Leak/Splash39
Patient problems
- No Clinical Signs, Symptoms or Conditions1,908
- No Consequences Or Impact To Patient936
- No Known Impact Or Consequence To Patient21
- No Patient Involvement17
- Foreign Body In Patient13
- Vascular Dissection10
- No Code Available5
- Perforation of Vessels4
Sterling models
153 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Sterling™ H74939031604010CATHETER, PERCUTANEOUS171 reports
- Sterling™ H74939031504010CATHETER, PERCUTANEOUS128 reports
- Sterling™ H74939032504040CATHETER, PERCUTANEOUS123 reports
- Sterling™ H74939031704010CATHETER, PERCUTANEOUS115 reports
- Sterling™ H74939032604040CATHETER, PERCUTANEOUS109 reports
- Sterling™ H74939031804010CATHETER, PERCUTANEOUS105 reports
- Sterling™ H74939031606010CATHETER, PERCUTANEOUS89 reports
- Sterling™ H74939032404040CATHETER, PERCUTANEOUS80 reports
- Sterling™ H74939031502210Catheter, angioplasty, peripheral, transluminal73 reports
- Sterling™ H74939031501110Catheter, angioplasty, peripheral, transluminal70 reports
- Sterling™ H74939031601110Catheter, angioplasty, peripheral, transluminal69 reports
- Sterling™ H74939031404010CATHETER, PERCUTANEOUS68 reports
- Sterling™ H74939031601610Catheter, angioplasty, peripheral, transluminal68 reports
- Sterling™ H74939031706010CATHETER, PERCUTANEOUS65 reports
- Sterling™ H74939031501610Catheter, angioplasty, peripheral, transluminal63 reports
- Sterling™ H74939031602210Catheter, angioplasty, peripheral, transluminal62 reports
- Sterling™ H74939031506010CATHETER, PERCUTANEOUS61 reports
- Sterling™ H74939032504080CATHETER, PERCUTANEOUS58 reports
- Sterling™ H74939031806010CATHETER, PERCUTANEOUS1 death58 reports
- Sterling™ H74939031702010CATHETER, PERCUTANEOUS51 reports
- Sterling™ H74939031406010CATHETER, PERCUTANEOUS49 reports
- Sterling™ H74939031602010CATHETER, PERCUTANEOUS49 reports
- Sterling™ H74939031502010CATHETER, PERCUTANEOUS48 reports
- Sterling™ H74939031304010CATHETER, PERCUTANEOUS48 reports
- Sterling™ H74939032604080CATHETER, PERCUTANEOUS43 reports
- Sterling™ H74939031302010CATHETER, PERCUTANEOUS41 reports
- Sterling™ H74939032404080CATHETER, PERCUTANEOUS36 reports
- Sterling™ H74939031802010CATHETER, PERCUTANEOUS35 reports
- Sterling™ H74939031402010CATHETER, PERCUTANEOUS34 reports
- Sterling™ H74939031306010CATHETER, PERCUTANEOUS31 reports
- Sterling™ H74939032704080CATHETER, PERCUTANEOUS29 reports
- Sterling™ H74939032602210Catheter, angioplasty, peripheral, transluminal27 reports
- Sterling™ H74939032404010CATHETER, PERCUTANEOUS25 reports
- Sterling™ H74939032402040CATHETER, PERCUTANEOUS24 reports
- Sterling™ H74939032601080CATHETER, PERCUTANEOUS24 reports
- Sterling™ H74939032604010CATHETER, PERCUTANEOUS22 reports
- Sterling™ H74939032804080CATHETER, PERCUTANEOUS21 reports
- Sterling™ H74939032504010CATHETER, PERCUTANEOUS19 reports
- Sterling™ H74939031503010CATHETER, PERCUTANEOUS19 reports
- Sterling™ H74939032501510Catheter, angioplasty, peripheral, transluminal19 reports
- Sterling™ H74939032302210Catheter, angioplasty, peripheral, transluminal19 reports
- Sterling™ H74939031403010CATHETER, PERCUTANEOUS18 reports
- Sterling™ H74939032704040CATHETER, PERCUTANEOUS17 reports
- Sterling™ H74939032501080CATHETER, PERCUTANEOUS16 reports
- Sterling™ H74939032104080CATHETER, PERCUTANEOUS15 reports
- Sterling™ H74939032601010CATHETER, PERCUTANEOUS15 reports
- Sterling™ H74939032502210Catheter, angioplasty, peripheral, transluminal15 reports
- Sterling™ H74939032601510Catheter, angioplasty, peripheral, transluminal15 reports
- Sterling™ H74939032501010CATHETER, PERCUTANEOUS13 reports
- Sterling™ H74939032904080CATHETER, PERCUTANEOUS13 reports
- Sterling™ H74939032606010CATHETER, PERCUTANEOUS12 reports
- Sterling™ H74939032502040CATHETER, PERCUTANEOUS11 reports
- Sterling™ H74939032401010CATHETER, PERCUTANEOUS11 reports
- Sterling™ H74939032602040CATHETER, PERCUTANEOUS11 reports
- Sterling™ H74939031303010CATHETER, PERCUTANEOUS11 reports
- Sterling™ H74939031603010CATHETER, PERCUTANEOUS11 reports
- Sterling™ H74939032602080CATHETER, PERCUTANEOUS10 reports
- Sterling™ H74939032704010CATHETER, PERCUTANEOUS10 reports
- Sterling™ H74939032804040CATHETER, PERCUTANEOUS10 reports
- Sterling™ H74939032902080CATHETER, PERCUTANEOUS10 reports
- Sterling™ H74939032300410Catheter, angioplasty, peripheral, transluminal10 reports
- Sterling™ H74939032402210Catheter, angioplasty, peripheral, transluminal10 reports
- Sterling™ H74939032102080CATHETER, PERCUTANEOUS9 reports
- Sterling™ H74939032401080CATHETER, PERCUTANEOUS9 reports
- Sterling™ H74939032402080CATHETER, PERCUTANEOUS9 reports
- Sterling™ H74939032601210Catheter, angioplasty, peripheral, transluminal9 reports
- Sterling™ H74939032502080CATHETER, PERCUTANEOUS8 reports
- Sterling™ H74939032602110Catheter, angioplasty, peripheral, transluminal8 reports
- Sterling™ H74939032506010CATHETER, PERCUTANEOUS7 reports
- Sterling™ H74939032406010CATHETER, PERCUTANEOUS7 reports
- Sterling™ H74939032804010CATHETER, PERCUTANEOUS7 reports
- Sterling™ H74939032508010CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939032702080CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939032802080CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939031353010CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939031453010CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939031553010CATHETER, PERCUTANEOUS6 reports
- Sterling™ H74939032502110Catheter, angioplasty, peripheral, transluminal6 reports
- Sterling™ H74939031401510Catheter, angioplasty, peripheral, transluminal6 reports
- Sterling™ H74939032202210Catheter, angioplasty, peripheral, transluminal6 reports
- Sterling™ H74939032300490Catheter, angioplasty, peripheral, transluminal6 reports
- Sterling™ H74939032300610Catheter, angioplasty, peripheral, transluminal6 reports
- Sterling™ H74939032502010CATHETER, PERCUTANEOUS5 reports
- Sterling™ H74939032102010CATHETER, PERCUTANEOUS5 reports
- Sterling™ H74939032702210Catheter, angioplasty, peripheral, transluminal5 reports
- Sterling™ H74939032200410Catheter, angioplasty, peripheral, transluminal5 reports
- Sterling™ H74939032252210Catheter, angioplasty, peripheral, transluminal5 reports
- Sterling™ H74939032302290Catheter, angioplasty, peripheral, transluminal5 reports
- Sterling™ H74939032506080CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939032408010CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939032902010CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939032904010CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939031354010CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939031454010CATHETER, PERCUTANEOUS4 reports
- Sterling™ H74939032601590Catheter, angioplasty, peripheral, transluminal4 reports
- Sterling™ H74939032602090Catheter, angioplasty, peripheral, transluminal4 reports
- Sterling™ H74939031501510Catheter, angioplasty, peripheral, transluminal4 reports
- Sterling™ H74939032104010CATHETER, PERCUTANEOUS3 reports
- Sterling™ H74939032402010CATHETER, PERCUTANEOUS3 reports
- Sterling™ H74939032606080CATHETER, PERCUTANEOUS3 reports
Recent Sterling adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952629 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that dissection occurred, requiring additional intervention.On (b)(6) 2026, the subject underwent treatment with the Eluvia Drug-Eluting Stent as part of the clinical trial. The target lesion #001 was located in the right mid superficial femoral artery, with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, a lesion length of 290 mm, and 95% stenosis, and was classified as a Trans-Atlantic Inter-Society Consensus (TASC II) C lesion. Prior to treatment with the study devices, pre-dilation was performed using a 5 mm X 220 mm Sterling OTW PTA balloon. Treatment of the target lesion was performed using 6 mm X 150 mm and 6 mm x 120 mm Eluvia Drug-Eluting Stents, followed by dilation with a 5 mm x 40 mm Ranger Drug-Coated Balloon. Following treatment, post-dilation was performed using a 6 mm x 150 mm Sterling OTW PTA balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2026, during treatment of the target lesion, a grade D dissection was noted in the right mid superficial femoral artery. The site confirmed that the 5 mm x 220 mm Sterling OTW PTA balloon was associated with the dissection. In response to the event,
Patient problems: Vascular Dissection
MAUDE report 50673764 ↗MalfunctionSep 2, 2026Entrapment of Device; Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569607 ↗MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280356 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left vessel below the knee. A 5.0mmX100mmX150cm (4F) Sterling balloon catheter was advanced for dilation. However, when the balloon was pressurized during the second inflation for 30 seconds, the balloon ruptured. 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 50274622 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. A 6.0mmX60mmX135cm (4F) Sterling balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 10 atmospheres 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 50274614 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified cephalic vein. A 7.0mmX40mmX80cm (4F) Sterling balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon second 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 50274603 ↗MalfunctionAug 17, 2026Material Rupture
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery. A 6.0mmX150mmX150cm (4F) Sterling 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 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 50274594 ↗MalfunctionAug 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260561 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209656 ↗MalfunctionAug 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209647 ↗MalfunctionAug 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156125 ↗InjuryJul 21, 2026Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BALLOON BURST, REQUIRING ADDITIONAL INTERVENTION. DURING AN ANGIOGRAM AND ANGIOPLASTY OF THE LEG, A 3.0X220X90 MM STERLING BALLOON CATHETER WAS INFLATED ONCE. THE BALLOON BURST AT A PRESSURE BELOW THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT, HOWEVER, IT WAS NOT INITIALLY RECOGNIZED THAT A PORTION OF THE BALLOON HAD SEPARATED AND REMAINED IN THE PATIENT. A CONTRAST ANGIOGRAM IDENTIFIED THE BALLOON FRAGMENT IN THE LOWER LEG. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A SNARE, AND ANOTHER STERLING BALLOON CATHETER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED, THE PATIENT WAS STABLE AND WAS DISCHARGED, AND FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25898383 ↗MalfunctionJul 20, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25876857 ↗MalfunctionJun 10, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0MMX20MMX135CM (4F) STERLING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459256 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page