Sterling™ H74939032502010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729122838), received between Jun 25, 2019 and Sep 26, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN BRACHIAL ARTERY. A 5.0MM X 20MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THE BALLOON PART WAS KINK AND STUCK INSIDE THE LESION. THE DEVICE WAS REMOVED INSIDE THE PATIENT WITHOUT ANY MISHAPS USING A BUNCH OF DIFFERENT CATHETERS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17820132 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. DURING UNPACKING OF A 5.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER, WHILE PREPARING THE BALLOON FOR USE, THE TECHNICIAN NOTICED THAT THE BALLOON LOOKED SEPARATED FROM THE SHAFT WITH LITTLE MANIPULATION AND APPLICATION OF NEGATIVE PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870931 ↗
• MalfunctionJan 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURY REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266719 ↗
• MalfunctionAug 7, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON AND WIRE BECAME STUCK DURING THE PROCEDURE. A 5.0MMX20MMX135CM (4F) STERLING BALLOON AND A V-18 CONTROL WIRE WERE SELECTED FOR A DIFFICULT AND COMPLEX PROCEDURE TO TREAT A RUPTURED FEWAR PROSTHESIS, A FENESTRATED PROSTHESIS WITH MANY OUTLETS INCLUDING THE KIDNEY. THERE WAS NO STENOSIS OR CALCIFICATION AT THIS SITE. THE PATIENT WAS SERIOUSLY ILL AT THE TIME OF THE PROCEDURE. THE PHYSICIAN INTENDED TO REBUILD THE RENAL ARTERY ON THE LEFT, SINCE THE NON-BSC STENT, WHICH HAD BEEN PREVIOUSLY IMPLANTED, WAS COMPLETELY TORN. THE PHYSICIAN WANTED TO PLACE A NEW STENT OVER THE OLD STENT. THE DOCTOR TRIED TO PROBE THE VESSEL WITH THE V18 WIRE AND FINALLY MANAGED TO GET IT THROUGH THE MESHES OF THE UNDERLYING STENT WITH THE STERLING BALLOON BY DILATING THE AREA TO MAKE A SMALL LUMEN. AFTER THIS, THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON FROM THE V18 WIRE, SO THAT A STENT COULD BE PASSED OVER THE V18 WIRE, BUT THE BALLOON AND THE WIRE COULD NOT BE SEPARATED. NO KINKS WERE NOTED ON THE WIRE THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE PHYSICIAN PULLED BOTH DEVICES OUT OF THE PATIENT TOGETHER LOOSING ACCESS TO THE TARGET SITE. THERE WAS AN INABILITY TO REGA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8870934 ↗
• MalfunctionJun 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING PREPARATION OF A 5.0MMX20MMX135CM STERLING BALLOON CATHETER, IT WAS NOTED THAT BEFORE FLUSHING, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH 5X40MM BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8731149 ↗