Sterling™ H74939032601010Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729123682), received between Sep 25, 2018 and Aug 17, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280356 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. TWO 6.0MMX100MMX135CM-HYBRID STERLING WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE LASER TREATMENT, THE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND ANOTHER BALLOON WAS ADVANCED. DURING FIRST INFLATION AT NOMINAL PRESSURE FOR 15 SECONDS, THE BALLOON WAS ALSO RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255210 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. TWO 6.0MMX100MMX135CM-HYBRID STERLING WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE LASER TREATMENT, THE BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND ANOTHER BALLOON WAS ADVANCED. DURING FIRST INFLATION AT NOMINAL PRESSURE FOR 15 SECONDS, THE BALLOON WAS ALSO RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255181 ↗
• MalfunctionJun 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.1/3.1 JETSTREAM WAS USED TO INITIALLY CROSS THE LESION FOLLOWED WITH A 6.0MMX100MMX135CM-HYBRID STERLING BALLOON CATHETER USED FOR DILATION. IT WAS NOT USED TO POST-DILATE A PREVIOUSLY PLACED STENT. DURING THE PROCEDURE, ON THE FIRST INFLATION AT APPROXIMATELY 8 -10 ATMOSPHERES INFLATED FOR APPROXIMATELY 5-10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH A DIFFERENT BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556742 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR A COUPLE OF SECONDS, THE BALLOON RUPTURED. THE WHOLE BALLOON SYSTEM WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17964651 ↗
• MalfunctionDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0MM X 100MM X 135CM-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 6.0 X 200 CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON DEFLATED AND REMOVED INTACT FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973460 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED, THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED, TARGET LESION WAS LOCATED IN THE NON-TORTUOUS. AND MODERATELY CALCIFIED DISTAL OF SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM, HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED. AND 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 11552581 ↗
• MalfunctionFeb 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX100MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11288854 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM STERLING CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY ISSUE NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878282 ↗
• MalfunctionFeb 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734402 ↗
• MalfunctionFeb 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701231 ↗
• MalfunctionOct 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS HAS OBTAINED VIA THE CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX135CM-HYBRID STERLING BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260154 ↗
• MalfunctionMay 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED VESSEL IN THE LEFT LOWER EXTREMITY. A 6.0MMX100MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING THE FIRST INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER 5.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. 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 8638743 ↗
• MalfunctionOct 12, 2018Entrapment of Device; Inflation Problem; Material Deformation; Entrapment of Device; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE STENOSED TARGET LESIONS WERE LOCATED IN THE POSTERIOR TIBIAL ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA) IN THE RIGHT LEG. A 6.0MMX100MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS PREPARED AND FLUSHED WITH SALINE. THE DEVICE WAS THEN ADVANCED THROUGH THE V-18 GUIDE WIRE INSIDE THE SFA AND WAS INFLATED ONCE. HOWEVER, IT WAS NOTICED THAT THERE WAS A LITTLE TOUGH WIRE MOVEMENT IN THE BALLOON. THE BALLOON WAS INFLATED AGAIN BUT FAILED TO INFLATE. IT WAS NOTED THAT THE BALLOON PASSAGE WAS KINKED FROM THE PROXIMAL PART BECAUSE THE V-18 GUIDE WIRE GOT STUCK INSIDE THE BALLOON. THE DEVICES WERE SLOWLY REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961497 ↗
• MalfunctionSep 25, 2018Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-SEP-2018. IT WAS REPORTED THAT TIP DAMAGED OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN POSTERIOR TIBIAL ARTERY. THE TARGET LESION WAS DELIVERED THRU A V-18 WIRE AND A NON BSC SHEATH. A 6.0MMX100MMX135CM-HYBRID FG STERLING OTW WAS USED TO DILATE THE LESION. WHEN BALLOONS WERE ATTEMPTED, A KINK IN THE CATHETER NEAR THE TIP OF THE BALLOON WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE RETURNED DEVICE ANALYSIS REVEALED A HOLE IN THE INNER SHAFT FROM THE TIP. DEVICE EVALUATED BY MANUFACTURER: THE BALLOON WAS LOOSELY FOLDED AND THERE WAS BLOOD ON THE BALLOON. MICROSCOPIC EXAMINATION REVEALED A HOLE IN THE INNER SHAFT 5.5CM FROM THE TIP, KINKED BALLOON AND INNER SHAFT AT 9.7CM FROM THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905812 ↗