Sterling® SL H74939148251510Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729782278), received between Aug 20, 2018 and Feb 3, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 10, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT BALLOON AIR LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHILE ATTEMPTING TO INFLATE THE BALLOON, IT WAS OBSERVED THAT THERE WAS NO PRESSURE, INDICATING A POTENTIAL AIR LEAK. AS A RESULT, THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21820861 ↗
• MalfunctionOct 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MIDDLE THIRD OF THE POSTERIOR TIBIAL ARTERY. A 2.5MM X 150MM X 150CM STERLING SL WAS ADVANCED FOR ANGIOPLASTY OF LOWER LIMBS. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DRUG ELUTING BALLOON. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436463 ↗
• MalfunctionAug 9, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS OBSERVED THAT THE INNER PACKAGING HAD AN OPENING. THE DEVICE WAS NOT USED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951690 ↗
• MalfunctionJul 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS DAMAGED WITHOUT REACHING THE WORKING PRESSURE AND WAS RUPTURED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND LOCAL ANESTHESIA WAS ADMINISTERED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735323 ↗
• MalfunctionMay 21, 2024Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A LOWER EXTREMITY ARTERIAL BALLOON DILATATION WAS PERFORMED, AND THE PATIENT'S ANTERIOR TIBIAL ARTERY WAS DILATED AFTER DISTAL ENTRY USING A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER. THE DEVICE WAS REMOVED FROM THE BODY UNDER NEGATIVE PRESSURE AND THE POSTERIOR TIBIAL ARTERY OF THE PATIENT WAS REPROCESSED. THE RUPTURING PRESSURE WAS MAINTAINED FOR TWO MINUTES, AND THE BALLOON WAS UNABLE TO RE-ENTER THE LESION THROUGH THE GUIDEWIRE. THE GUIDEWIRE COULD NOT BE TAKEN OUT OF THE BALLOON. WHEN THE WHOLE SYSTEM WAS PULLED OUT OF THE BODY, IT WAS DISCOVERED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM THE BALLOON. THE BALLOON ITSELF WAS TWISTED AND COULD NO LONGER BE USED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE REMAINDER OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. NO ADDITIONAL INTERVENTION WAS PERFORMED WHEN REMOVING THE BALLOON DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358676 ↗
• MalfunctionMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 5% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED BENEATH THE KNEE. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON WAS LEAKING, AND A PINHOLE WAS NOTED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529470 ↗
• MalfunctionJun 3, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LOWER LEFT LIMB. DURING PREPARATION OF A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER, IT WAS FLUSHED WITH SALINE USING A 10ML SYRINGE THROUGH THE WIRE LINE. HOWEVER, IT WAS NOTICED THAT LITTLE WATER COMES OUT OF THE DISTAL END OF THE CATHETER. A V-18 GUIDE WIRE WAS PASSED THROUGH THE BALLOON BUT IT DID NOT EXIT IN THE DISTAL END OF THE CATHETER AND IT ENTERED NEAR THE FIRST RO MARK. THE GUIDE WAS REMOVED AND IT WAS NOTED TO BE DEFORMED. SUBSEQUENTLY, THE FLUSHING WAS AGAIN PERFORMED BUT THE BALLOON BEGINS TO BE INFLATED EVEN THOUGH THE SOLUTION IS BEING INJECTED THROUGH THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED ARTERY. AFTER THE GUIDEWIRE EXITED THE SHAFT, IT EXITED TO THE BALLOON WITHOUT PERFORATING THE BALLOON MATERIAL AND WHEN IT WAS REMOVED, A SMALL PERFORATION/FRACTURE ON THE SHAFT NEAR THE FIRST RO MARKER WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115245 ↗
• MalfunctionOct 22, 2018Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND CALCIFIED FEMORAL PROFOUND ARTERY. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE IT WAS NOTED THAT THE BALLOON COULD NOT UNFOLD NORMALLY, THERE WAS CONTRAST LEAKING FROM THE MID SECTION OF THE BALLOON AND THERE WAS BLOOD ENTERING THE BALLOON. 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'S STATUS WAS STABLE. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON WAS LOOSELY FOLDED WITH BLOOD IN THE BALLOON AND INFLATION LUMEN. THE TIP, BALLOON, MARKERBANDS, PROXIMAL BOND, INNER SHAFT AND OUTER SHAFT WERE MICROSCOPICALLY AND VISUALLY INSPECTED. INSPECTION REVEALED A KINK AND INNER SHAFT DAMAGE (PUNCTURE) LOCATED 59 CM FROM THE TIP OF THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TEST WAS CONDUCTED BY ATTACHING AN INFLATION DEVICE (FOILED WITH WATER) TO THE HUB OF THE STERLING SL DEVICE. WHEN POS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992161 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN A LOWER LIMB. A 2.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798036 ↗