Sterling SLRecalls & reported problems across all models
Boston Scientific Corporation · 35 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 183
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 35 models of Sterling SL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2018 and Jul 9, 2026 — classified as 11 injuries, 172 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (114 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 SL problems
Device problems
- Material Rupture114
- Leak/Splash22
- Inflation Problem15
- Detachment of Device or Device Component13
- Break12
- Entrapment of Device10
- Adverse Event Without Identified Device or Use Problem8
- Difficult to Remove8
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- No Consequences Or Impact To Patient58
- Foreign Body In Patient5
- Device Embedded In Tissue or Plaque2
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
- Thrombosis/Thrombus1
Sterling SL models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sterling® SL H74939148301510CATHETER, PERCUTANEOUS40 reports
- Sterling® SL H74939148301010CATHETER, PERCUTANEOUS20 reports
- Sterling® SL H74939148401510CATHETER, PERCUTANEOUS19 reports
- Sterling® SL H74939148251510CATHETER, PERCUTANEOUS10 reports
- Sterling® SL H74939148308010CATHETER, PERCUTANEOUS10 reports
- Sterling® SL H74939148201510CATHETER, PERCUTANEOUS9 reports
- Sterling® SL H74939148251210CATHETER, PERCUTANEOUS8 reports
- Sterling® SL H74939148301210CATHETER, PERCUTANEOUS7 reports
- Sterling® SL H74939148401210CATHETER, PERCUTANEOUS7 reports
- Sterling® SL H74939148201210CATHETER, PERCUTANEOUS6 reports
- Sterling® SL H74939148301090CATHETER, PERCUTANEOUS6 reports
- Sterling® SL H74939148251010CATHETER, PERCUTANEOUS5 reports
- Sterling® SL H74939148301590CATHETER, PERCUTANEOUS5 reports
- Sterling® SL H74939148201010CATHETER, PERCUTANEOUS3 reports
- Sterling® SL H74939148351510CATHETER, PERCUTANEOUS3 reports
- Sterling® SL H74939148401010CATHETER, PERCUTANEOUS3 reports
- Sterling® SL H74939148208010CATHETER, PERCUTANEOUS2 reports
- Sterling® SL H74939148201590CATHETER, PERCUTANEOUS2 reports
- Sterling® SL H74939147351210CATHETER, PERCUTANEOUS2 reports
- Sterling® SL H74939148258010CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148351010CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148351210CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148201090CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148251090CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148251290CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148251590CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148301290CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148308090CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148351590CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939148401290CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939147201010Catheter, angioplasty, peripheral, transluminal1 report
- Sterling® SL H74939147301010Catheter, angioplasty, peripheral, transluminal1 report
- Sterling® SL H74939147301510Catheter, angioplasty, peripheral, transluminal1 report
- Sterling® SL H74939147308010CATHETER, PERCUTANEOUS1 report
- Sterling® SL H74939147358010Catheter, angioplasty, peripheral, transluminal1 report
Recent Sterling SL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED AND DEVICE FRAGMENT REMAINED INSIDE THE PATIENT AND WAS REMOVED WITH A RETRIEVAL DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 2 MINUTES, THE BALLOON RUPTURED AND FRACTURED. THE DEVICE FRAGMENTS REMAINED INSIDE THE BODY; THEREFORE, A RETRIEVAL DEVICE (SNARE) WAS USED TO REMOVE THE FRAGMENTS. THIS INCIDENT DELAYED THE SURGICAL PROCEDURE AND INCREASED THE SURGICAL DURATION. 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 25771522 ↗MalfunctionJul 7, 2026Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 3.0MM X 80MM X 150CM STERLING WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AND MATERIAL FROM THE BALLOON AND BALLOON MARKER REMAINED IN THE PATIENT. THE BALLOON MATERIAL WAS SECURED IN THE DISSECTION MEMBRANE AND FIXED WITH A STENT. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND A STENT WAS PLACED.
Patient problems: Foreign Body In Patient; Vascular Dissection
MAUDE report 25738396 ↗MalfunctionMar 31, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90-100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED TIBIAL AND POPLITEAL ARTERY. A 4.0MM X 100MM X 135CM (4F) STERLING AND 3.0MM X 150MM X 150CM STERLING SL BALLOON WERE SELECTED FOR USE. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE 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 24741145 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE BALLOON WAS LEAKING. A 4.0MM X 150MM X 150CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. THE 60% TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING DEVICE PREPARATION, IT WAS OBSERVED THAT THE BALLOON WAS LEAKING GAS. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369135 ↗MalfunctionFeb 3, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND BETWEEN MODERATE AND SEVERELY CALCIFIED VESSEL IN THE FOREARM. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 20 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 24248827 ↗MalfunctionJan 14, 2026Material Rupture
IT WAS REPORTED THAT BALLOON PERFORATED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.5MM X 150MM X 150CM STERLING SL WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A PRESSURE DROP WAS OBSERVED DURING THE INITIAL INFLATION, WHICH WAS MAINTAINED FOR APPROXIMATELY 30 SECONDS. THE BALLOON HEAD WAS SUBSEQUENTLY FOUND TO BE PERFORATED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST PROCEDURE AND THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069941 ↗MalfunctionDec 22, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04DEC2025. IT WAS REPORTED THAT A LEAK OCCURRED. A STERLING BALLOON WAS SELECTED FOR USE TO TREAT LOWER EXTREMITY ARTERY OCCLUSION. THE BALLOON HAD A PROBLEM WHEN IT CROSSED THE ILIOFEMORAL ARTERY. IT RETRACTED IMMEDIATELY AFTER DILATION AND COULD NOT BE SUCCESSFULLY DILATED. THE DEVICE WAS REPLACED WITH A NEW STERLING BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 83MM FROM THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871914 ↗MalfunctionDec 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LOWER EXTREMITY ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON BURST AND COULD NOT BE RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOWER EXTREMITY ARTERY. DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 100 SECONDS, THE BALLOON RUPTURED. THE PATIENTS ANATOMY WAS FOUND TO BE CHALLENGING, BUT PATIENT-RELATED FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, NO PROCEDURAL FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE OCCURRENCE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23860287 ↗MalfunctionNov 20, 2025Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24OCT2025. IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE PROPERLY. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER LIMB. A 2.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR LOWER LIMB ANGIOPLASTY TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 102MM FROM THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607919 ↗MalfunctionNov 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON DILATING THE BALLOON IT WAS NOTED THAT IT COULD NOT INFLATED AND WAS RUPTURED. 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 23518724 ↗MalfunctionNov 7, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE CHALLENGING, 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM STERLING SL WAS SELECTED FOR USE IN A PERCUTANEOUS ARTERIAL BALLOON DILATATION OF LOWER EXTREMITY. DURING WITHDRAWAL, THE BALLOON WAS KINKED, AND IT COULD NOT BE WITHDRAWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496410 ↗MalfunctionNov 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 4.0MM X 150MM X 150 CM STERLING BALLOON CATHETER WAS ADVANCED FOR VESSEL DILATATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE (RBP). NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME. IT WAS FURTHER REPORTED THAT THE TARGET LESION, WITH 95% STENOSIS, WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SEGMENT OF THE POPLITEAL TO DISTAL SUPERFICIAL FEMORAL ARTERY. DURING THE INITIAL INFLATION, WHICH LASTED 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE BALLOON. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477475 ↗MalfunctionOct 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 60-YEAR-OLD MALE PATIENT UNDERWENT A BALLOON ANGIOPLASTY FOR RIGHT LOWER EXTREMITY ARTERIAL OCCLUSION. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE INITIAL BALLOON CATHETER WAS DAMAGED DUE TO VESSEL CALCIFICATION AND FAILED TO INFLATE PROPERLY. THE BALLOON WAS RUPTURES ONCE AT 10 ATMOSPHERE PER SECOND. AFTER INFLATION, THE CONTRAST AGENT LEAKED OUT AND THE BALLOON RETRACTED RAPIDLY. THE BALLOON WAS REMOVED ALONG THE GUIDE WIRE. 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 23373714 ↗InjuryOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTER THAT BALLOON DETACHMENT OCCURRED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS SHEERED OFF AND A CUTDOWN WAS NEEDED TO RETRIEVE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337075 ↗MalfunctionOct 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH A LEFT LOWER EXTREMITY ARTERY OCCLUSION. A 3.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED ALONG WITH THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON BURST AND COULD NOT BE DILATED. THE DEVICE WAS REMOVED, 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 23334750 ↗
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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.
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