Sterling™ H74939031604010Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 08714729757290), received between Sep 27, 2018 and Apr 13, 2026 — classified as 1 injury, 170 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (163 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. 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 24860295 ↗
• MalfunctionApr 1, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT EXTERNAL ILIAC ARTERY (ITEIA). A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 15 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 24758134 ↗
• MalfunctionApr 1, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING 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, 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 24756781 ↗
• MalfunctionMar 25, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE THIRD 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 24685780 ↗
• MalfunctionMar 8, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 3 SECONDS, 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 24541751 ↗
• MalfunctionFeb 18, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION ABOUT 12 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 24378549 ↗
• MalfunctionFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 6 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 24283585 ↗
• MalfunctionDec 15, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT FAILURE TO DEFLATE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER COULD NOT BE FULLY DEFLATED FOLLOWING THE FIRST INFLATION AT 15 ATMOSPHERES FOR 10 SECONDS. AS A RESULT, THE DEVICE WAS FORCIBLY PULLED INTO THE SHEATH AND REMOVED. 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 23810673 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 3 SECONDS, 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 23448848 ↗
• MalfunctionOct 16, 2025Material Rupture; Material 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 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED FROM A PINHOLE LOCATED AT NEAR THE TIP. 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 23309417 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM FG STERLING MR, BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION UNTIL IT REACHES 6 ATMOSPHERES. 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 23289739 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961944 ↗
• MalfunctionJul 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY RIGHT EXTERNAL ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR FIVE SECONDS, THE BALLOON RUPTURED AND VERTICALLY SEPARATED FROM THE MIDDLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649189 ↗
• MalfunctionJul 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461838 ↗
• MalfunctionJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, UNTIL IT REACHED 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379279 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 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 22130404 ↗
• MalfunctionMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 ATMOSPHERES, 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 22115385 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING 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 22036842 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE ILIAC. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT AROUND 10 ATMOSPHERES, THE BALLOON 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 21937719 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUBCLAVIAN ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON VERTICALLY RUPTURED AT THE MIDDLE OF THE BALLOON. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735481 ↗
• MalfunctionMar 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE BRACHIOCEPHALIC ARTERY. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR FEW SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600951 ↗
• MalfunctionMar 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0MMX40MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558381 ↗
• MalfunctionJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277614 ↗
• MalfunctionJan 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 3 ATMOSPHERES FOR 10 SECOND. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182755 ↗
• MalfunctionJan 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182715 ↗