Sterling™ H74939032803080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729720669), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT A NEW ACCESS SITE WAS CREATED IN ORDER TO DEFLATE THE BALLOON. AN 8.0MM X 30MM X 80CM 4F STERLING WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE OCCLUDED ARTERIOVENOUS SHUNT VESSEL. DURING THE PROCEDURE, THE BALLOON FAILED TO FULLY DEFLATE. WHILE ATTEMPTING TO WITHDRAW, THE STERLING COULD NOT BE REMOVED THROUGH THE 4F NON-BOSTON SCIENTIFIC INTRODUCER SHEATH. THE PATIENT WAS PUNCTURED AGAIN AND A RETRACTION CANNULA WAS USED TO PIERCE AND DEFLATE THE BALLOON. THE STERLING WAS REMOVED FROM THE SHEATH AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727826 ↗