Sterling™ H74939032200410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729859932), received between Apr 15, 2019 and Feb 7, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE BELOW THE KNEE VESSEL. A 2.0X40X150 MM STERLING BALLOON CATHETER WAS ADVANCED TO PERFORM DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED MULTIPLE TIMES; HOWEVER, A PINHOLE RUPTURE OCCURRED IN THE BALLOON TOWARD THE END OF THE PROCEDURE. THE COMPROMISED DEVICE WAS SUCCESSFULLY WITHDRAWN, AND THE INTERVENTION WAS COMPLETED USING ANOTHER IDENTICAL CATHETER. NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337640 ↗
• MalfunctionDec 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT LOWER LIMB ANGIOPLASTY. A 2.0X40X150 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, A CONTRAST LEAKAGE AT THE BALLOON SHAFT WAS OBSERVED BEFORE INFLATING THE BALLOON. ADDITIONALLY, A PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH A 2X60X150CM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914630 ↗
• MalfunctionApr 11, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. A 2.0X40X150 (4F) STERLING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT INFLATE IN THE TARGET LESION. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093148 ↗
• MalfunctionAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0X40X150MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928535 ↗
• MalfunctionApr 15, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON THE GUIDEWIRE OCCURRED. VASCULAR ACCESS WAS GAINED WITH ANTEGRADE APPROACH. THE 80 PERCENT STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NORMALLY TORTUOUS ANTERIOR TIBIALIS ARTERY IN THE LOWER LEG. A NON-BSC SHEATH WAS PLACED. A 20/300 V-18 CONTROL WIRE WAS ADVANCED. A 2.0X40X150 (4F) STERLING BALLOON CATHETER WAS INTRODUCED OVER THE GUIDEWIRE. THE STENOSIS WAS DILATED WITH THE STERLING BALLOON. AFTER SUCCESSFUL DILATION, AN ATTEMPT TO PULL BACK THE BALLOON WAS MADE; HOWEVER THIS WAS NOT POSSIBLE. THE BALLOON AND THE GUIDEWIRE WERE PULLED OUT OF THE PATIENT TOGETHER. THE PROCEDURE WAS CONSIDERED COMPLETED. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516303 ↗