Sterling™ H74939032506010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729122937), received between Oct 2, 2019 and Jul 3, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JUN2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE LOWER EXTREMITY ARTERY. A 5.0MMX60MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669074 ↗
• MalfunctionApr 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS TAKEN OUT AND DISPOSED AND REPLACED FOR A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED ON THE FIRST INFLATION WHEN IT WAS IN THE PROCESS OF INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181489 ↗
• MalfunctionSep 7, 2023Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD) AND ANGIOGRAM WAS PERFORMED TO FIX A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN EXTERNAL ILIAC TO SUPERFICIAL FEMORAL ARTERY THE 100% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON BURST. THE BALLOON WAS THEN ATTEMPTED TO BE REMOVED BUT IT WAS DIFFICULT; HENCE, THE PHYSICIAN PULLED THE DEVICE WITH FORCE AND THE BALLOON SNAPPED IN HALF. SINCE THE BALLOON HAD BURST; DOUBLE NEGATIVE PRESSURE WAS APPLIED TO DEFLATE AND PULLED THE BALLOON IN AS CLOSE AS POSSIBLE TO THE SHAFT. TOGETHER WITH THE WIRE, THE BALLOON WAS FRACTURED WHEN REMOVED SUCCESSFULLY AND NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. A NEW STERLING BALLOON CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698100 ↗
• MalfunctionFeb 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR ANGIOGRAM IN THE LEG. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE INFLATING THE BALLOON AT NOMINAL PRESSURE DURING PROCEDURE, THE BALLOON LEAKED AND POPPED. THE DEVICE WAS REMOVED FROM THE BODY. A NEW OF SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362578 ↗
• MalfunctionDec 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 5.0 X 60 STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931339 ↗
• MalfunctionDec 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10976778 ↗
• MalfunctionOct 2, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. DURING PREPARATION OF A 5.0MM X 60MM X 135CM (4F) STERLING BALLOON CATHETER, IT WAS NOTICED THAT THE INNER DEVICE POUCH WAS SLIGHTLY OPEN UPON INSPECTION. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9146380 ↗