Sterling™ H74939032504010Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729122906), received between Jul 9, 2019 and Jul 29, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS VESSEL. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT). DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND A DAMAGE WAS OBSERVED ON THE DEVICE. 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 22649186 ↗
• MalfunctionMar 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL ABOVE THE KNEE. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BURST BEFORE REACHING THE RATED BURST PRESSURE DURING INFLATION. THE DEVICE WAS REMOVED CAREFULLY AND SLOWLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501390 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material 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 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742115 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON ILIAC AND SUPERFICIAL FEMORAL ARTERIES. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, ANOTHER 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED BUT ALSO RUPTURED ON THE FIRST INFLATION AT AROUND 12 ATMOSPHERES FOR 15 SECONDS. BOTH DEVICES WERE REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069611 ↗
• InjuryMay 11, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND VESSEL DISSECTION OCCURRED, AND REMOVAL DIFFICULTIES WERE ENCOUNTERED REQUIRING ADDITIONAL INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS COMMON FEMORAL ARTERY. A 5.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. A 50/50 CONTRAST AND SALINE WERE USED. THE BALLOON WAS INFLATED AT 14 ATMOSPHERES FOR APPROXIMATELY 20 SECONDS WITH NO APPARENT ISSUES. HOWEVER, WHEN NEGATIVE PRESSURE WAS APPLIED FOR 5 MINUTES TO THE ENCORE 26 INFLATION DEVICE, THE BALLOON DID NOT DEFLATE. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON MULTIPLE TIMES BUT WITH NO SUCCESS. AS THE BALLOON WAS UNABLE TO BE REMOVED, A MICRO PUNCTURE NEEDLE WAS USED TO PUNCTURE THE BALLOON THROUGH THE SKIN INTO THE ARTERY, BUT THE ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE WHOLE SYSTEM INCLUDING THE SHEATH AND THE INFLATED BALLOON WERE REMOVED THROUGH THE INSERTION POINT OF ARTERY. THE PHYSICIAN RE-ENTERED ANOTHER SHEATH AND A STENT WAS REQUIRED DUE TO DISSECTION, CAUSED BY THE PREVIOUS INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 16908819 ↗
• MalfunctionJan 26, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. WHEN REMOVING A 5.0MMX40MMX135CM STERLING BALLOON CATHETER FROM THE PACKAGING, IT WAS NOTICED THAT THE BALLOON MATERIAL WAS TEAR, AND A SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246218 ↗
• MalfunctionMay 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430856 ↗
• MalfunctionApr 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERIOR MESENTERIC ARTERY (SMA). A 8 5.0MM X 40MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED AT 10 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244630 ↗
• MalfunctionApr 22, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT CEPHALIC VEIN. A 5.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS HELD TO 10 ATMOSPHERES, HOWEVER, IT WOULD NOT INFLATE. WHEN IT WAS REMOVED FROM THE BODY, IT WAS NOTED TO BE FULLY DEFLATED AND WHEN ATTEMPTED TO INFLATE OUTSIDE THE BODY, IT DID FINALLY INFLATE, BUT IT WOULD NOT DEFLATE AT ALL. THE PROCEDURE WAS COMPLETED WITH A 5X40 NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187128 ↗
• MalfunctionNov 9, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING DEFLATION, THE BALLOON FAILED TO DEFLATE. THE PROCEDURE WAS CANCELLED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780233 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. FOLLOWING DILATATION WITH A NON-BSC BALLOON CATHETER, A 5.0MMX40MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, DISSECTION OCCURRED. THE PHYSICIAN STATED THAT DISSECTION WAS DUE TO THE ANGIOPLASTY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 11725462 ↗
• MalfunctionFeb 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330379 ↗
• MalfunctionJan 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN ARTERY. A 5.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11237771 ↗
• MalfunctionDec 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11100037 ↗
• MalfunctionDec 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOTIC TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT LOWER ARM FISTULA. A 5.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 2 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11097739 ↗
• MalfunctionOct 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER A GUIDEWIRE CROSSED THE LESION, A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. DILATATION WAS PERFORMED WITH A NON-BSC BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED AFTER PLACEMENT OF A NON-BSC STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177297 ↗
• MalfunctionOct 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED THE 99% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL POPLITEAL VESSEL. THE LESION HAD A FOCAL CHUNK OF CALCIUM NOTED WITH LITTLE TO NO TORTUOSITY. AT SOME POINT DURING THE PROCEDURE, TWO 5.0MMX40MMX135CM STERLING BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 5X40 CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145993 ↗
• MalfunctionOct 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED THE 99% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL POPLITEAL VESSEL. THE LESION HAD A FOCAL CHUNK OF CALCIUM NOTED WITH LITTLE TO NO TORTUOSITY. AT SOME POINT DURING THE PROCEDURE, TWO 5.0MMX40MMX135CM STERLING BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 5X40 CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145970 ↗
• MalfunctionJul 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0MMX40MMX135CM (4F) AND A 4.0MMX100MMX135CM (4F) STERLING BALLOON CATHETERS WERE ADVANCED FOR DILATATION CONSECUTIVELY. HOWEVER, BOTH BALLOONS RUPTURED UPON INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773223 ↗