Sterling™ H74939032501210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729845348), received between Aug 26, 2020 and Nov 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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 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.

• MalfunctionNov 13, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22OCT2025. IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO CROSS THE LESION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0X120X150 STERLING CATHETER WAS SELECTED FOR RENAL ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURES. THE DEVICE DID NOT ADVANCE WELL WITHIN THE BLOOD VESSELS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BALLOON HAD A RUPTURE AT 7CM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542543 ↗
• MalfunctionAug 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. A 6.0MMX80MMX135CM-HYBRID STERLING WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE PRODUCT INNER POUCH DID NOT MATCH THE OUTER SHELF CARTON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966685 ↗
• MalfunctionAug 26, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19AUG2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. A 5.0X120X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10455156 ↗