Sterling™ H74939032202210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729859970), received between Mar 6, 2019 and Feb 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY, FROZE ON WIRE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 2.0X220X150 (4F) STERLING AND A V-18 CONTROL WIRE GUIDEWIRE WERE SELECTED FOR USE IN THE LOWER EXTREMITY TO TREAT PERIPHERAL ARTERY DISEASE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND DEFLATED. AN ATTEMPT TO REMOVE THE BALLOON OFF OF THE WIRE WAS MADE; HOWEVER, THE BALLOON REMAINED STUCK ON THE WIRE AND THE SHAFT BROKE. THE BALLOON CATHETER AND THE GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC 018 GUIDEWIRE AND AN ALTERNATE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236134 ↗
• MalfunctionJan 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MILD TO MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION BEFORE REACHING THE NOMINAL BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120862 ↗
• MalfunctionFeb 11, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-FEB-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND A VESSEL BELOW THE KNEE. A 2.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED TWICE THEN A CONTRAST LEAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315097 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND BELOW THE KNEE VESSEL. A 2.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY PULLED OUT AND COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878812 ↗
• MalfunctionAug 27, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LONG TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE BECAME KINKED DURING THE PROCEDURE. THE DEVICE WAS REMOVED WITH DIFFICULTY AS IT COULD NOT BE REMOVED WITHOUT HAVING TO REMOVE THE WIRE AS WELL. THE ENTIRE SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934736 ↗
• MalfunctionMar 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 2.0X220X150 (4F) FG STERLING OTW BALLOON CATHETER WAS SELECTED FOR USE. DURING ATHERECTOMY, IT WAS NOTED THAT THERE WAS A LOW PRESSURE AT ABOUT 7-8 ATMOSPHERES AND THE BALLOON BURST. OPTICROSS IMAGING CATHETER WAS USED ON THE ACTUAL CONSOLE OF THE DEVICE AND THE IMAGE WENT BLACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENTS STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395820 ↗