Sterling™ H74939032200610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729859956), received between Nov 25, 2019 and Jul 31, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING SURGICAL INTERVENTION. THE 70% STENOSED TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. DURING ANGIOPLASTY, A 2.0X60X150 STERLING BALLOON CATHETER WAS ADVANCED AND INFLATED AT 6 ATMOSPHERES FOR 30 SECONDS. HOWEVER, DURING REMOVAL, THE BALLOON SHAFT BROKE OFF AND WAS LEFT IN THE PATIENT. IT WAS FURTHER OBSERVED DURING PALPATION ON A MANUAL PRESSURE HOLD, THAT THE ACCESSED SITE WAS HARD AND UNUSUAL. FINALLY, THE PHYSICIAN CUT THE ACCESS SITE OPEN AND REMOVED THE SHEARED BALLOON WITH A PAIR OF HEMOSTATS. THE DEVICE WAS REMOVED FULLY DEFLATED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 17426785 ↗
• MalfunctionFeb 27, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT LOWER EXTREMITY. A 2.0X60X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN USED IT THE FIRST TIME, IT WORKED SUCCESSFULLY ON A PORTION OF THE VESSEL, HOWEVER, WHEN IT WAS TOOK BACK AND USED IT AGAIN, IT DID NOT DEFLATED ENOUGH AND GET SMALL ENOUGH TO TRACK BACK DOWN OVER THE WIRE. A 2X80X150 NON-BSC BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764151 ↗
• MalfunctionNov 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. DURING THE PROCEDURE, IT WAS NOTED THAT THE 2.0 X 60 X 150, 4F STERLING BALLOON RUPTURED DURING POST DILATION PRIOR TO REACHING NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE BALLOON RUPTURED UPON FIRST INFLATION FOR 2-3 SECONDS AND WAS REMOVED OVER GUIDEWIRE. THE PATIENT'S CONDITION POST PROCEDURE WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371162 ↗