Sterling™ H74939032501010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729122814), received between Jan 21, 2020 and Jan 8, 2026 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THE BALLOON FAILED TO DEFLATE. THE 90% TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PERIPHERAL ARTERY. A5.0 MM X 100 MM X 135 CM (4F) STERLING WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT THE NOMINAL PRESSURE OF 6 ATMOSPHERES OVER SEVERAL MINUTES. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT FULLY DEFLATE AND WOULD NOT COME OUT OF THE SHEATH. WHEN PULLING NEGATIVE ON THE INFLATOR, THE PHYSICIAN COULD HEAR AIR BEING SUCKED IN. THERE WAS NO VISIBLE HOLE IN THE BALLOON. THE BALLOON WAS EVENTUALLY REMOVED IN A PARTIALLY INFLATED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003830 ↗
• MalfunctionDec 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A STERLING BALLOON WAS SELECTED FOR USE. THE BALLOON RUPTURED BEFORE IT WAS INFLATED TO ITS NOMINAL BURST PRESSURE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE BALLOON RUPTURED DURING FIRST INFLATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882393 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED EXTERNAL ILIAC ARTERY. A 5.0 MM X 100 MM X 135 CM (4F) STERLING BALLOON AND V-18 GUIDEWIRE WERE SELECTED FOR ABDOMINAL AORTA AND RIGHT LOWER EXTREMITY ARTERIOGRAPHY AND RIGHT EXTERNAL ILIAC ARTERY BALLOON DILATION STENT IMPLANTATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME ENTANGLED WITH THE GUIDEWIRE AND COULD NOT BE PUSHED AND WITHDRAWN. THE BALLOON AND GUIDEWIRE WERE SIMULTANEOUSLY PULLED OUT, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC GUIDEWIRE AND ANOTHER 5.0 MM X 100 MM STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437242 ↗
• MalfunctionMay 13, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON COULD NOT BE REMOVED FROM THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 5.0MMX100MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, AFTER INFLATION, IT WAS NOTED THAT THE BALLOON COULD NOT BE REMOVED FROM THE GUIDEWIRE. AS A RESULT, BOTH THE GUIDEWIRE AND THE BALLOON HAD TO BE REMOVED TOGETHER AND RESELECT THE VESSEL WITH A NEW GUIDEWIRE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009629 ↗
• MalfunctionFeb 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 5.0MMX100MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457265 ↗
• MalfunctionNov 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE THORACIC AORTA. A 5.0 MM X 100 MM X 135 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT TARGET LESION WAS 75% STENOSED, MODERATELY TORTUOUS AND NON-CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650290 ↗
• MalfunctionAug 1, 2023Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DIFFICULT TO REMOVE OCCURRED. A 5.0MMX100MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING THE PROCEDURE THE BALLOON FAILED TO INFLATE. THE DOCTOR HAD TO PULL THE WHOLE SYSTEM OUT INCLUDING THE SHEATH AND IT HAD TO BE CUT TO GET THE SHEATH OFF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436033 ↗
• MalfunctionApr 10, 2023Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT THERE WERE DEFLATION ISSUES, AND THE PROCEDURE WAS RESCHEDULED. A FG STERLING OTW, 5.0MMX100MMX135CM (4F) WAS SELECTED FOR THE INDEX PROCEDURE. AFTER INFLATION, HOWEVER, THE BALLOON WASN'T ABLE TO BE DEFLATED. THE BALLOON HAD TO BE PULLED BACK TOGETHER WITH THE SHEATH OUT OF THE PATIENT. BECAUSE THE POSITION OF THE SHEATH WAS LOST, THE PROCEDURE WAS DISCONTINUED AND SCHEDULED TO BE COMPLETED IN THE FUTURE. THE PATIENT STATUS IS STABLE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708934 ↗
• MalfunctionJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS FIRST INFLATED AT 8 ATMOSPHERES (ATM) FOR 30 SECONDS. HOWEVER, DURING SECOND INFLATION AT 10 ATM FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958429 ↗
• MalfunctionMar 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). 6F NON-BOSTON SCIENTIFIC SHEATH WAS PLACED AND A GUIDEWIRE WAS USED TO CROSS THE LESION. FOLLOWING INTRAVASCULAR ULTRASOUND (IVUS), A 5.0 MM X 100 MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND WAS REPLACED WITH ANOTHER OF A 5MMX 4CM STERLING BALLOON CATHETER. DILATATION WAS WAS PERFORMED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED AFTER ANGIOGRAPHIC CHECKING WAS DONE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11443754 ↗
• MalfunctionAug 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A FAILURE TO MAINTAIN PRESSURE OCCURRED. A 5.0MMX100MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON FAILED TO HOLD PRESSURE AFTER IT WAS BEING INFLATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10357120 ↗
• MalfunctionMar 10, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW BALLOON DEFLATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0MMX100MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON WAS EXTREMELY DIFFICULT TO INFLATE AND DEFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT WHEN IT GOT DEFLATED FROM THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812065 ↗
• MalfunctionJan 21, 2020Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  IT WAS REPORTED THAT A BALLOON WOULD NOT DEFLATE PROPERLY. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS BEING PERFORMED IN THE ILIAC ARTERY. AFTER INFLATION, THE 5MM X 100MM X135CM STERLING BALLOON WAS UNABLE TO PROPERLY DEFLATE. SEVERAL NEGATIVE PRESSURES WERE APPLIED IN ORDER TO DEFLATE THE BALLOON WITHOUT SUCCESS. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE BALLOON SYSTEM FROM THE PATIENT'S BODY WHILE PARTIALLY INFLATED AT APPROXIMATELY 6-10 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9614310 ↗