Sterling® SL H74939148208010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729782247), received between Dec 21, 2018 and Dec 18, 2023 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0MM X 80MM X 150CM STERLING BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO THE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION WAS 80% STENOSED AND WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347341 ↗
• MalfunctionDec 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 50% STENOSED 200X 1.5TO 4MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DORALIS PEDIS ARTERY. A 2.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE DEVICE WAS PLACED IN THE LESION TO PERFORMED THE PLASTY, IT WAS NOTED THAT THERE WAS BLOOD FLOW IN THE INSUFFLATOR AND THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED AND OUTSIDE THE PATIENT'S BODY, IT WAS INSUFFLATED AND WAS CONFIRMED THAT IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190354 ↗