Sterling™ H74939032602110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729845478), received between Aug 20, 2019 and Nov 20, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2024. IT WAS REPORTED THAT ADVANCING DIFFICULTIES AND SHAFT KINK OCCURRED. A 6.0X200X150-HYBRID STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE BALLOON CATHETER WAS KINKED FROM THE INSIDE AND A LOT OF RESISTANCE WAS FELT WHEN ADVANCING OVER WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE AT THE KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737841 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL SUPERFICIAL ARTERY. A 16.0X200X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 5 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527499 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE SAFETY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS. THE TARGET LESION 1 WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 220 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 100 MM AND 6 MM X 200 MM STERLING PTA BALLOONS AND 3 MM X 80 MM NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING OF TWO 6 MM X 150 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES. POST TARGET LESION TREATMENT WAS PERFORMED BY PLACEMENT OF NON-BOSTON SCIENTIFIC STENT AND DILATION USING 6.0 MM X 150 MM STERLING PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. HOWEVER, DURING TREATMENT OF TARGET LESION 1, DISSECTION OF GRADE D WAS NOTED DUE TO BOSTON SCIENTIFIC (BSC) ADJUNCTIVE DEVICE 6 MM X

  Patient problems: Vascular Dissection

  MAUDE report 17461965 ↗
• InjuryJun 7, 2023Break; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 6.0X200X150-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION, THE BALLOON WAS RUPTURED AND FRACTURED WITHIN THE BODY. THE BROKEN FRAGMENTS WERE RETRIEVED WITH A SNARE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079451 ↗
• MalfunctionFeb 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6.0X200X150 STERLING BALLOON WAS SELECTED FOR USE IN A POST DILATATION PROCEDURE IN THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS CALCIFIED. DURING THE PROCEDURE ON THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408097 ↗
• MalfunctionNov 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 6.0X200X150 STERLING BALLOON CATHETER WAS ADVANCED BUT ALSO RUPTURED AFTER BEING INFLATED AT NOMINAL PRESSURE. THE DEVICE WAS ALSO REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871307 ↗
• MalfunctionAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200 X 150MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. DILATATION WAS PERFORMED AGAIN WITH ANOTHER 6.0 X 200 X 150MM STERLING BALLOON CATHETER. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON ALSO RUPTURED. A THIRD BALLOON OF THE SAME DEVICE WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912506 ↗
• MalfunctionAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMOARAL ARTERY. A 6.0 X 200 X 150 MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. DILATATION WAS PERFORMED AGAIN WITH ANOTHER 6.0 X 200 X 150 MM STERLING BALLOON CATHETER. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON ALSO RUPTURED. A THIRD BALLOON OF THE SAME DEVICE WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912505 ↗