Sterling™ H74939032704010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729124078), received between Apr 1, 2019 and Mar 9, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552623 ↗
• InjuryNov 24, 2025Difficult to Remove; Material Rupture; Failure to Deflate; Difficult to Remove; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED, REQUIRING THE SHAFT OF THE BALLOON TO BE CUT FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE DEVICE WAS THEN INFLATED A SECOND TIME TO NOMINAL PRESSURE; HOWEVER, WHEN ATTEMPTING TO REMOVE PRESSURE, THE BALLOON BURST. NO FRAGMENTATION OCCURRED. WHEN ATTEMPTING TO PULL BACK THROUGH THE SHEATH, RESISTANCE WAS FELT. THE BALLOON WAS UNABLE TO FULLY DEFLATE DUE TO THE RUPTURE. THE PHYSICIAN HAD TO CUT THE SHAFT OF THE BALLOON TO LET PRESSURE TRICKLE OUT TO BE ABLE TO REMOVE BALLOON FROM THE SHEATH. 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 23639455 ↗
• InjuryNov 22, 2024Adverse 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 DEFLATION ISSUES OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH THROMBOSIS OF VENOUS SINUS AND UNDERWENT THROMBECTOMY AND ANGIOPLASTY. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN PULLED NEGATIVE WITH SYRINGE AND PULLED BACK ON THE SHAFT TO MAKE SURE THERE WERE NO KINKS, BUT THE BALLOON WOULD NOT DEFLATE. TRIED USING A SUCTION DEVICE BUT THE BALLOON WOULD STILL NOT DEFLATE. A VASCULAR SURGEON WAS CALLED IN AND CUT THE SHAFT OF THE BALLOON AND THEN FORCEFULLY PULLED THE BALLOON THROUGH THE GUIDE SHEATH. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761249 ↗
• MalfunctionJul 11, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE PATIENT UNDERWENT ANGIOPLASTY OF THE 50% STENOSED TARGET LESION WITH MIXED MORPHOLOGY LOCATED IN THE MILDLY TO MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. AFTER GAINING VASCULAR ACCESS VIA THE RIGHT COMMON FEMORAL ARTERY WITH A 6FR SHEATH, A 300CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS ADVANCED DEEP INTO THE AORTA AND INTO THE TARGET LESION. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS PREPPED AND ADVANCED OVER GUIDEWIRE INTO THE EXTERNAL ILIAC FOR PRE-DILATION. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES AND WORKED PERFECTLY; HOWEVER, DURING WITHDRAWAL, THE BALLOON WAS STUCK ON THE GUIDEWIRE. FLUSHING, INFLATING, AND DEFLATING THE BALLOON WAS TRIED BUT IT WOULD NOT COME OFF THE GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE PULLED OUT INTACT TOGETHER THROUGH THE SHEATH AND A NEW GUIDEWIRE WAS USED TO ACCESS THE LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299509 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A FISTULA IN A NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED AT THE FIRST LESION WITH NO ISSUES AND WAS THEN MOVED TO THE SECOND LOCATION. HOWEVER, DURING INFLATION, THE DISTAL END OF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028994 ↗
• InjuryJan 9, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE MILDLY CALCIFIED TARGET LESION WAS 100% OCCLUDED AND LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) / POPLITEAL ARTERY. ATHERECTOMY AND BALLOON ANGIOPLASTY WITH A 5.0MM BALLOON WAS PERFORMED. A NON-BOSTON SCIENTIFIC (BSC) STENT WAS IMPLANTED. THE STENT WAS DOUBLE LAYERED OVER A PREVIOUSLY PLACED NON-BSC STENT, AND THE NEW STENT HAD FOLDED ONTO ITSELF DURING ITS DEPLOYMENT. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED TO POST DILATE THE STENT. THE STERLING WAS PASSED OVER THE WIRE AND INFLATED ONCE TO APPROXIMATELY 10 ATMOSPHERES, IN A NORMAL LOOKING PORTION OF THE STENT; HOWEVER, THE BALLOON FAILED TO DEFLATE. THE PHYSICIAN TRIED SEVERAL METHODS AND DEVICES AND COULD NOT DEFLATE THE DEVICE. FINALLY, THE PHYSICIAN WAS ABLE TO RUPTURE THE BALLOON USING A NON-BSC RE-ENTRY DEVICE. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THE STENT REMAINED PATENT AND WAS ASYMPTOMATIC ONE WEEK POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122513 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258676 ↗
• MalfunctionJan 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11130266 ↗
• MalfunctionJul 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LEFT LEG. A 7.0MM X 40MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 2 PSI, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND UPON TRYING TO INFLATE THE BALLOON, A HOLE WAS NOTED. THE PROCEDURE WAS COMPLERTED WITH ANTHER OF THE SAME DEVICE. NO PATIENT COMMPLCAITIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8760231 ↗
• MalfunctionApr 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON FEMORAL ARTERY. A 7.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471296 ↗