Sterling™ H74939032608010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729123828), received between Aug 31, 2018 and May 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL TO PERONEAL TO SUPERFICIAL FEMORAL ARTERY. A 6.0MMX80MMX135CM-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 10-12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED IN ONE PIECE, AND NOTHING LEFT INSIDE THE PATIENTS' BODY. A NEW BALLOON WAS USED AND COMPLETED THE PROCEDURE WELL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016146 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2018, CLINICAL STATUS ASSESSMENT IDENTIFIED THE SUBJECT'S QUALIFYING CONDITION AS RUTHERFORD CATEGORY 3. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) HAD 100% STENOSIS, WITH A REFERENCE VESSEL DIAMETER OF 6 MM, A LENGTH OF 7 MM AND WAS CLASSIFIED UNDER UNKNOWN TASC II LESION. TARGET LESION WAS TREATED WITH PRE-DILATATION USING 6 MM X 80 MM BALLOON. FOLLOWING PRE-DILATATION, THE TARGET LESION WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING 6 MM X 80 MM STERLING PTA BALLOON. POST-STANDARD PTA TREATMENT, GRADE 'C' DISSECTION WAS NOTED WHICH WAS TREATED WITH BARE METAL STENT BAILOUT. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 7837577 ↗