Sterling® SL H74939148251010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729782254), received between Sep 17, 2018 and Oct 26, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023Inflation Problem; Material Rupture; Material Integrity Problem; Inflation Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A LESS THAN 50% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED PERONEAL ARTERY. A 2.5MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE RADIOPAQUE MARKERS WERE NOT AT THE RIGHT SPOT ON THE BALLOON. HOWEVER, DURING THE FIRST INFLATION AT LESS THAN 2 ATMOSPHERES FOR LESS THAN 1 SECOND, THE BALLOON RUPTURED WHEN IT WAS REMOVED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011986 ↗
• MalfunctionJun 8, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-MAY-2022. IT WAS REPORTED THAT BALLOON INFLATION ISSUE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 2.5MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THERE WAS NO PRESSURE IN THE BALLOON FROM THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633449 ↗
• MalfunctionMay 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS BEING PERFORMED ON A 90% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS LESION BELOW THE KNEE. THE SHEATH WAS LOCATED ANTEGRADELY AND THE STENOSIS IN THE LOWER LEG WAS EXPLORED WITH A V-18 CONTROLWIRE GUIDEWIRE. THE 2.5MM X 100MM X 150CM STERLING SL BALLOON WAS ADVANCED OVER THE V18 GUIDEWIRE INTO THE STENOSIS AND RUPTURED UPON INFLATION AT 18 ATMOSPHERES. A SECOND STERLING SL BALLOON WAS USED AND ALSO RUPTURED IN THE SAME PLACE. THE BALLOON RUPTURES WERE DUE TO VERY HARD CALCIFICATION. THE STENOSIS WAS RESOLVED DESPITE THIS AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603019 ↗
• MalfunctionMay 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS BEING PERFORMED ON A 90% STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS LESION BELOW THE KNEE. THE SHEATH WAS LOCATED ANTEGRADELY AND THE STENOSIS IN THE LOWER LEG WAS EXPLORED WITH A V-18 CONTROLWIRE GUIDEWIRE. A 2.5MM X 100MM X 150CM STERLING SL BALLOON WAS ADVANCED OVER THE V18 GUIDEWIRE INTO THE STENOSIS AND RUPTURED UPON INFLATION AT 18 ATMOSPHERES. THIS SECOND 2.5MM X 100MM X 150CM STERLING SL BALLOON WAS USED AND ALSO RUPTURED IN THE SAME PLACE. THE BALLOON RUPTURES WERE DUE TO VERY HARD CALCIFICATION. THE STENOSIS WAS RESOLVED DESPITE THIS AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600406 ↗
• MalfunctionSep 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIAL OCCLUSION IN THE LOWER LIMB. A 2.5MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION WITHIN SPECIFIED PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND 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 7883176 ↗