Sterling™ H74939032606010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729123804), received between Apr 5, 2019 and Aug 11, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209656 ↗
• MalfunctionSep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED FEMORAL ARTERY. A 6.0 MM X 60 MM X 135 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS 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 23038501 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX60MMX135CM (4F) 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 23017909 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON ILIAC AND SUPERFICIAL FEMORAL ARTERIES. A 5.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, ANOTHER 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED BUT ALSO RUPTURED ON THE FIRST INFLATION AT AROUND 12 ATMOSPHERES FOR 15 SECONDS. BOTH DEVICES WERE REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072731 ↗
• InjuryMar 29, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE AND UNDERWENT ANGIOPLASTY IN AN OCCLUDED ARTERY. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED USING THE STANDARD PROCEDURE; HOWEVER, THE BALLOON WOULD NOT DEFLATE WHEN NEGATIVE PRESSURE WAS APPLIED MULTIPLE ATTEMPTS. THE WHOLE SYSTEM HAD TO BE WITHDRAWN AS THE BALLOON COULD NOT BE REMOVED THROUGH THE SHEATH LEAVING A MUCH LARGER HOLE IN THE PATIENT'S ARTERY. ADDITIONAL INTERVENTIONS WERE REQUIRED TO CLOSE THE ARTERY PROLONGING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635359 ↗
• MalfunctionJan 26, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0MMX60MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DEVICE WAS INSERTED VIA SHEATH AND CROSSED THE LESION FINE BUT ONCE INFLATED, THE BALLOON WOULD NOT DEFLATE REGARDLESS OF MULTIPLE ATTEMPTS TO DEFLATE, EXERCISING ENDOFLATOR AND EXCHANGING WIRES. THE BALLOON, WIRE AND SHEATH WERE ALL REMOVED TOGETHER. THE BALLOON WAS STILL INFLATED AT TIME OF REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247896 ↗
• MalfunctionApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND CALCIFIED LEFT FEMORAL ARTERY. A 6.0MMX60MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960718 ↗
• MalfunctionApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BUSTED. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS BUSTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9957197 ↗
• InjuryNov 18, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED AND HAD TO BE SURGICALLY REMOVED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY BYPASS. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON FAILED TO DEFLATE. THE PHYSICIAN POPPED THE INFLATED BALLOON TO PROCEED WITH DEVICE REMOVAL. HOWEVER, THE BALLOON CATHETER COULD NOT BE REMOVED THROUGH THE 4F NON- BSC SHEATH. THE BALLOON CATHETER WAS SURGICALLY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336705 ↗
• MalfunctionSep 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117866 ↗
• MalfunctionJun 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LEGS. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING NORMAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680602 ↗
• MalfunctionApr 5, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY HEAVILY CALCIFIED LEFT RENAL ARTERY. A 6.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, THE BALLOON GOT STUCK ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE AND BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486812 ↗