Sterling® SL H74939148301210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729782308), received between May 2, 2019 and Sep 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 3.0MM X 120MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3X120 BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065249 ↗
• MalfunctionAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NOT TORTUOUS BELOW THE KNEE VESSEL. A 3.0MM X 120MM X 150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON DEMONSTRATED LIMITED DEFLATION. AT A PRESSURE OF 9 ATMOSPHERES, THE BALLOON RUPTURED FOR THREE SECONDS. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN INTACT WITHOUT COMPLICATION. THE PROCEDURE WAS COMPLETED USING 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 22853923 ↗
• MalfunctionFeb 3, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND WAS DIFFICULT TO REMOVED. THE TARGET LESION WAS A MODERATELY CALCIFIED. A 3.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE. THE STERLING SL CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED UPON INFLATION AND WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294706 ↗
• MalfunctionMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MODERATELY CALCIFIED VESSEL ARTERY. A 3.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294183 ↗
• MalfunctionMar 18, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERO TIBEAL ARTERY. AFTER A V18 WIRE WAS CROSSED THE LESION. A 3.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE PRESSURE OF THE BALLOON WAS NOT INCREASING AFTER IT WAS BEING INFLATED. WHEN THE DEVICE WAS REMOVED, THE PHYSICIAN INFLATED IT AGAIN AND A PORE HOLE WAS NOTICED AT THE CONNECTION BETWEEN THE BALLOON AND THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847938 ↗
• MalfunctionJan 17, 2020Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. A 3.0MMX120MMX150CM STERLING SL BALLOON WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS LOCATED BELOW-THE-KNEE (BTK) WITH 85% STENOSIS. DURING THE PROCEDURE INSIDE THE PATIENT, THE BALLOON FAILED TO DEFLATE PROPERLY AFTER IT WAS INFLATED. SEVERAL NEGATIVE PRESSURES WERE TRIED, BUT IT WAS UNABLE TO NOT DEFLATED. UPON REMOVAL, THE BALLOON BECAME STUCK TO THE PROXIMAL PART OF THE WIRE AND THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601797 ↗
• MalfunctionMay 2, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DEEP VEIN OF THE LOWER LIMB. A 3.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, RESISTANCE AT THE TIP OF THE BALLOON WAS ENCOUNTERED. THE DEVICE COULD NOT MOVE AND COULD NOT REACH THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON BUT THE BALLOON LUMEN AND THE GUIDE WIRE WERE STUCK AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT BOTH DEVICES WERE EVENTUALLY REMOVED TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576171 ↗