Sterling® SL H74939148401510Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729782384), received between Oct 29, 2018 and Feb 17, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WITH A SALINE-CONTRAST RATIO OF 70/30 WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AT 6 ATMOSPHERES PER MINUTE. UPON DEFLATION, IT WAS NOTED THAT THE BALLOON WAS VERY SLOW TO DEFLATE AND HARD TO REMOVE. THE PHYSICIAN WAITED FOR A FEW MINUTES FOR THE BALLOON TO DEFLATE AND WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170072 ↗
• MalfunctionJun 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GAS LEAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOWER LIMB ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THE BALLOON WAS LEAKING GAS WHILE INSIDE THE PATIENT. 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 22136415 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY TO POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON ENTERED THE LESION VESSEL, THE PUSH BAR WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286930 ↗
• MalfunctionMar 6, 2024Entrapment of Device; Detachment of Device or Device Component; Failure to Deflate; Entrapment of Device; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. A STERLING BALLOON CATHETER WAS SELECTED FOR USE TO TREAT STENOSIS IN THE PROXIMAL POPLITEAL ARTERY AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 97% OCCLUDED AND HEAVILY CALCIFIED. THE PROCEDURE STARTED AS AN OUTPATIENT PROCEDURE IN THE CARDIAC CATHETERIZATION LAB (CCL). INITIAL ANGIOGRAPHY SHOWED A TWO-VESSEL RUNOFF. THE TARGET LESION WAS CROSSED IN THE SUBINTIMAL PLANE. A NON-BSC BALLOON WAS USED TO DILATE THE SUBINTIMAL PLANE. A NON-BSC RE-ENTRY DEVICE WAS USED; HOWEVER, IT COULD NOT TRACK DOWN TO THE LESION. A 6X70CM SHEATH WAS SELECTED IN ORDER TO CREATE SOME PUSHABILITY FOR THE NON-BSC RE-ENTRY DEVICE, HOWEVER, THE RE-ENTRY DEVICE BROKE. A DIFFERENT NON-BSC RE-ENTRY DEVICE WAS SELECTED. HOWEVER, IT REPEATEDLY BECAME ENTRAPPED ON THE GUIDEWIRE. ADDITIONAL ANGIOGRAPHY AT THIS POINT REVEALED NO FLOW TO THE FOOT. AT THIS POINT, THE PHYSICIAN DECIDED THE PATIENT NEEDED TO BE MOVED TO THE OPERATING ROOM (OR) TO BE PLACED UNDER ANESTHESIA. ONCE IN THE OR, PEDAL ACCESS WAS OBTAINED, AND THE LESION WAS CROSSED. THE 70CM SHEATH WAS REPLACED WITH A NEW 6X45CM NON-BSC SHEATH. A STERLING BALLOON CATHETER WAS ADVANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848741 ↗
• MalfunctionMar 4, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-FEB-2024. IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OCCLUSION. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE IN DILATION. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOON WAS LEAKING FROM THE TIP UPON REACHING THE TARGET LESION WITH NO COMPLICATIONS FOR THE PATIENT. SUBSEQUENTLY, A SECOND BALLOON WAS UTILIZED TO REPLACE THE FIRST ONE, APPLYING 12ATM PRESSURE FOR 30 SECONDS. IT WAS EVIDENT THAT THE OPENING OF THE SUPERFICIAL FEMORAL ARTERY UNDERWENT LOCAL ELASTIC RETRACTION, AND A SUSPECTED SPIRAL DISSECTION WAS NOTICED AT THE PROXIMAL END. A BOSTON SCIENTIFIC STENT WAS THEN IMPLANTED, FOLLOWED BY POST-DILATATION WITHIN THE STENT USING A MUSTANG BALLOON AT 12ATM PRESSURE. THE SUPERFICIAL FEMORAL ARTERY REMAINED SMOOTH THROUGHOUT THE PROCESS, WITH NO RESIDUAL STENOSIS IN THE STENT OR EXTRAVASATION OF CONTRAST AGENT. THE DISTAL OUTFLOW TRACT MAINTAINED ITS PRE-PROCEDURE SMOOTHNESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826138 ↗
• InjuryJan 29, 2024Break; Material Rupture; Failure to Deflate; Break; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WAS SEPARATED AND WAS LEFT INSIDE THE PATIENT. THE MULTI FOCAL, GREATER THAN 150MM X 5MM, 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON AND A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, A BALLOON RUPTURE OCCURRED AT 14 ATMOSPHERES FOR ONE MINUTE UPON FIRST INFLATION. THE DEVICE WOULD NOT REDUCE UPON RAPID DEFLATION, SO IT WAS REMOVED ALONG THE WIRE UNTO THE SHEATH. HOWEVER, IN AN ATTEMPT TO REMOVED THE SHEATH, THE BALLOON SEPARATED, AND THE DISTAL TIP GOT STUCK ON THE WIRE. A BUDDY WIRE WAS INTRODUCED, AND IT WAS ATTEMPTED TO REMOVE THE ORIGINAL WIRE AND SHEATH WITH THE TIP ON THE WIRE, BUT THE BALLOON TIP LODGED IN THE RIGHT GROIN SUBCUTANEOUS TISSUE OF THE ACCESS SITE AND COULD NOT BE REMOVED. A SMALL CUT WAS DONE TO TRY TO REMOVED THE FRAGMENT, BUT WAS UNSUCCESSFUL, SO IT WAS LEFT IN PLACE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT IS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT, A FOLLOW UP CHECK UP ON THE PATIENTS STATUS WAS DONE THREE WEEKS IN A ROW WITH NO CHANGE

  Patient problems: Foreign Body In Patient

  MAUDE report 18601493 ↗
• MalfunctionAug 17, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY TO BRACHIAL ARTERY. AN 8F LONG NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH PUNCTURED IN SUPINE POSITION IN THE FEMORAL ARTERY. AFTER A V-18 GUIDEWIRE CROSSED THE LESION, A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PRESSURIZATION, THERE WAS LEAKAGE AT THE TAIL END OF THE BALLOON. THE DEVICE WAS REMOVED, AND IT WAS NOTICED A SPRAY AT THE TAIL END. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17562872 ↗
• InjuryAug 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHAFT DETACHED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE SHAFT FRACTURED. A STENT WAS IMPLANTED TO SECURE THE DETACHED COMPONENT AGAINST THE VESSEL WALL. A BALLOON WAS USED TO POST-DILATE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17548676 ↗
• MalfunctionDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED FEMORAL TO POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 14 ATMOSPHERES FOR 2 MINUTES, THE BALLOON BURST. NO SEGMENT OF THE BALLOON WAS DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924299 ↗
• MalfunctionDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16NOV2021. IT WAS REPORTED THAT AN UNKNOWN DEVICE ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. A 4.0MM X 150MM X 150CM STERLING SL WAS SELECTED FOR USE; HOWEVER, AN UNKNOWN DEVICE ISSUE WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE. HOWEVER, COMPLETED DEVICE ANALYSIS REVEALED THAT A GUIDEWIRE WAS STUCK INSIDE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920831 ↗
• MalfunctionJun 11, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL VESSEL. A 4.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS INFLATED MULTIPLE TIMES WITHOUT ANY ISSUE AND WAS REMOVED. HOWEVER, WHEN THE DEVICE WAS USED FOR ANOTHER PROCEDURE, THE 018 V18 GUIDEWIRE WAS PUSHING THROUGH THE BALLOON CATHETER SHAFT INSTEAD OF TRACKING THE WIRE SHAFT. THE DEVICE WAS REMOVED AND A POSSIBLE BREAK IN THE CATHETER SHAFT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO MATERIAL WAS LOST OR COMPLICATIONS DURING OR AFTER THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984742 ↗
• MalfunctionDec 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN IN THE RIGHT LOWER EXTREMITY. A 4.0MM X 150MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT MORE OR LESS THAN WORKING PRESSURE FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10945670 ↗
• MalfunctionSep 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS TRACKED APPROPRIATELY OVER THE WIRE TO TARGET IN THE POPLITEAL ARTERY. THE BALLOON WAS INFLATED AT 4 ATMOSPHERES WHEN IT BURST AND WOULD NOT INFLATE FURTHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10608258 ↗
• MalfunctionOct 29, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE STRAIGHT LAST THIRD OF SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY, IT WAS SOFT AND WAS 140MM LONG. A 4.0MM X 150MM X 150CM STERLING SL WAS SELECTED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE PRESSURE IN THE INSUFFLATOR WAS DESCENDING AT 1/2 ATMOSPHERES PER 2 SECONDS. THE BALLOON WAS ALSO LOSING PRESSURE, IT WAS NOTED UNDER FLUOROSCOPY. THE PHYSICIAN INDUCED AGAIN PRESSURE UNTIL IT REACH 8 ATMOSPHERES BUT NOTED THAT THE CONTRAST MEDIA WAS GOING OUT THROUGH THE WIRE PORT OF THE BALLOON HUB. THE PRESSURE WAS GOING DOWN AGAIN AT 1/2 ATMOSPHERES PER 2 SECONDS AND THE BALLOON WAS LOSING ITS DIAMETER. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015653 ↗