Sterling™ H74939032702210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729845560), received between Nov 26, 2018 and Dec 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Deflation Problem; Material Integrity Problem; Deflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON WAS SLOW TO DEFLATE. THE TARGET LESION WAS APPROXIMATELY 65% STENOSED AND LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER PLACING A 6FR 45CM NON-BOSTON SCIENTIFIC (BSC) SHEATH, A 014 THRUWAY GUIDEWIRE WAS ADVANCED INTO THE TIBIAL BRANCHES. THE TARGET LESION WAS TREATED WITH LASER ATHERECTOMY FOLLOWED WITH ANGIOPLASTY USING A 7.0X220150-HYBRID STERLING BALLOON CATHETER. THE BALLOON WAS PREPPED NORMALLY AND ADVANCED OVER THE WIRE WITHOUT ANY DIFFICULTY. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND THEN TAKEN TO BURST PRESSURE. HOWEVER, DURING INFLATION, IT WAS NOTED THAT A PART OF THE BALLOON WOULD NOT INFLATE. THE PRESSURE WAS NOT HELD LONG DUE TO THE VISUAL "FILLING" DEFECT ON THE BALLOON. DURING WITHDRAWAL, THE PHYSICIAN HAD TO WORK THE BALLOON INFLATOR BACK AND FORTH. THE BALLOON TOOK OVER 2 MINUTES TO DEFLATE AND WAS PULLED OUT OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311814 ↗
• MalfunctionSep 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED BY CONTRALATERAL APPROACH VIA GROIN. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY (FEM-POP) GRAFT. FOLLOWING LASER ATHERECTOMY, A 7.0X220150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 3-4 ATMOSPHERES, A BALLOON LEAK WAS NOTED. IT WAS OBSERVED THAT THERE WAS A HOLE IN THE BALLOON WHICH WOULD NOT ALLOW IT TO REACH NOMINAL PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED ONCE AND WAS REMOVED VIA STANDARD PIN/PULL TECHNIQUE. THE PATIENT HAD NO VESSEL INJURY AND WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698058 ↗
• MalfunctionOct 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHRONIC CRITICAL LIMB ISCHEMIA (CLI) AND UNDERWENT RIGHT LEG ANGIOGRAPHY WITH INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY. A 7.0X220150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 2 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 6.0 X 220 STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637478 ↗
• MalfunctionNov 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINCH OFF OCCURRED. A 7.0X220150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE BALLOON WAS FULLY INFLATED TO RATED BURST PRESSURE, A WASTE WAS NOTED IN THE MIDDLE OF THE BALLOON. THE DEVICE WAS THEN REMOVED AND INFLATED OUTSIDE AND IT SHOWED TO BE PINCHED OFF APPROXIMATELY IN THE MID PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871730 ↗
• MalfunctionNov 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7X100X120 EPIC VASCULAR STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A 7.0 X200, 135CM CHARGER AND A 7.7.0X220150-HYBRID STERLING BALLOON CATHETER WERE SELECTED FOR DILATATION. HOWEVER, BOTH BALLOONS RUPTURED BEFORE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT AND BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102114 ↗