Sterling™ H74939032601510Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729845447), received between Aug 6, 2019 and Sep 12, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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.

• MalfunctionSep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PROCEDURE THE BALLOON BURST DURING INFLATION WITHOUT REACHING THE BURST RATED PRESSURE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED FOR A PERIPHERAL ARTERIAL DISEASE AT THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR THE STERLING BALLOON AND TIBIAL ARTERY FOR THE COYOTE. THE TARGET LESION WAS APPROXIMATELY ABOVE 90% STENOSIS, NOT TORTUOUS, AND MODERATELY TO SEVERELY CALCIFIED. THE BALLOON RUPTURED AT THE FIRST INFLATION WHILE TAKING THE IT UP AT BELOW BURST PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041759 ↗
• MalfunctionJun 16, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0X150X150-HYBRID FG STERLING OTW BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS BURST. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213365 ↗
• MalfunctionMay 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150 X 150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION BEFORE THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094744 ↗
• MalfunctionAug 3, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUL2024. IT WAS REPORTED THAT THE BALLOON LEAKAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X150X150-HYBRID STERLING BALLOON WAS SELECTED FOR THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. HOWEVER, IT WAS NOTED THAT THE CONTRAST MEDIUM LEAKED OUT OF THE BALLOON AND DID NOT EXPAND DURING THE POST-BALLOON DILATATION. THE PROCEDURE WAS COMPLETED NORMALLY BY REPLACING IT WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE IN THE BALLOON 13.2CM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901371 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 6: 0X150X150-HYBRID STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667683 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 6.0X150X150-HYBRID STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667636 ↗
• MalfunctionOct 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE MAXIMUM PRESSURE, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948518 ↗
• InjuryFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT AND PERFORATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING A ROTATIONAL ATHERECTOMY PROCEDURE, A 6.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES FOR 1 MINUTE, THE CENTER PART OF THE BALLOON RUPTURED WHICH CAUSED THE BALLOON TO SPLIT IN HALF AND CAME DETACHED FROM THE BALLOON CATHETER WHICH MADE A SMALL PERFORATION IN SFA WITH MILD BLEEDING. THE BALLOON WAS FULLY DEFLATED FOR 30 SECONDS AND WAS PULLED OUT. IT WAS REALIZED THAT HALF OF THE BALLOON WAS STILL INSIDE PATIENT. A SNARE WAS USED TO CAPTURE, AND REMOVED THE DETACHED DEVICE FRAGMENT COMPLETELY. BALLOONING AND STENTING OVER THE AREA OF PERFORATION WERE PERFORMED TO ADDRESS PERFORATION AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT STATUS WAS GOOD POST-PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16368634 ↗
• MalfunctionFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY TO COMMON FEMORAL ARTERY. A 6.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16333825 ↗
• MalfunctionAug 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X150X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE MIDDLE PART OF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306304 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 6.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED BUT THE BALLOON ALSO RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. BOTH STERLING BALLOONS RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698493 ↗
• MalfunctionFeb 22, 2021Entrapment of Device; Failure to Advance; Difficult to Advance; Entrapment of Device; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CROSSOVER APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER THE LESION WAS CROSSED WITH A THRUWAY GUIDEWIRE AND PRE-DILATED WITH A 4MM BALLOON, A 6MM X 120MM AND 7MM X 120MM ELUVIA STENTS WERE IMPLANTED. A 6.0X150X150 STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATION BUT SEVERE RESISTANCE WAS ENCOUNTERED WHEN THE BALLOON STARTED TO COME OUT FROM THE TIP OF THE 6FR NON-BSC SHEATH AND IT COULD NOT BE DELIVERED SMOOTHLY INTO THE STENT. DELIVERY WAS PERFORMED WHILE RESISTANCE WAS FELT, AND INFLATION OF THE BALLOON WAS PERFORMED ABOUT 3 TIMES. HOWEVER, DURING REMOVAL, THE BALLOON WAS STUCK WITH THE GUIDE WIRE AND IT COULD NOT BE REMOVED. SUBSEQUENTLY, THE DEVICE WAS REMOVED AS A SET WITH THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362093 ↗
• MalfunctionJan 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL IN A LOWER EXTREMITY. A 6.0 X 150 X 150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 90 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11158655 ↗
• MalfunctionOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X150X150-HYBRID STERLING 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 WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202403 ↗
• MalfunctionAug 6, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X150X150-HYBRID STERLING BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS ATTEMPTED TO BE PULLED OUT OF THE HOOP, THE DEVICE WAS NOTED TO BE BROKEN AND KINKED NEAR THE HUB. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS JUST KINKED AND NOT BROKEN AS WHAT WAS PREVIOUSLY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8863065 ↗