Sterling™ H74939032508010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729122951), received between Sep 10, 2018 and Sep 19, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PERIPHERAL ARTERY. A 5.0MMX80MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102881 ↗
• MalfunctionMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE >80% STENOSED TARGET LESION WAS LOCATED IN A TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX80MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON LEAKED. IT WOULD NOT HOLD PRESSURE AFTER MULTIPLE INFLATIONS FOR 1-2 SECONDS, AND IT RUPTURED AT 2-4 ATMOSPHERES. ANOTHER 5.0X150X150-HYBRID STERLING BALLOON WAS USED, BUT IT ALSO RUPTURED AT 4 ATMOSPHERES FOR 5 SECONDS AFTER MULTIPLE ATTEMPTS OF INFLATION. BOTH BALLOONS WERE REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT. NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620213 ↗
• MalfunctionAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MMX80MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR LESS THAN 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440439 ↗
• MalfunctionMar 25, 2021Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT FAILURE TO DEFLATE, REMOVAL DIFFICULTIES, AND SHAFT BREAK WERE ENCOUNTERED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED EXTERNAL ILIAC ARTERY. A 5.0MMX80MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE PROCEDURE, THE BALLOON DID NOT FULLY DEFLATE. UPON WITHDRAWAL, THE DEVICE GOT STUCK WITHIN THE SHEATH AND THE BALLOON SHAFT BROKE. THE PARTIALLY INFLATED BALLOON WAS PULLED OUT THROUGH THE SHEATH ALONG WITH THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570872 ↗
• MalfunctionApr 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED POPLITEAL ARTERY. A 5.0MMX80MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE INITIAL INFLATION AT RATED BURST PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992135 ↗
• MalfunctionSep 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION TO A NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. A 5.0MMX80MMX135CM (4F) STERLING BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION TO A NOMINAL PRESSURE, THE BALLOON ALSO RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7860170 ↗