Sterling® SL H74939148201510Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729782230), received between Jul 7, 2020 and Sep 16, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE BALLOON LEAKED GAS OCCURRED. THE GREATER THAN 95% STENOSIS WAS LOCATED IN THE INFERIOR GENICULAR ARTERY. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON FAILED TO REACH WORKING PRESSURE DUE TO GAS LEAKAGE AND COULD NOT BE DILATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063620 ↗
• MalfunctionAug 20, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07AUG2024. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE, AND IT WAS NOTED THAT THE BALLOON UNABLE TO FULLY INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE 104MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006808 ↗
• MalfunctionJul 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INSIDE THE PATIENT BUT WAS DAMAGED AND RUPTURED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND LOCAL ANESTHESIA WAS ADMINISTERED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735686 ↗
• MalfunctionJun 26, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON TEAR WAS NOTED. A 2.0MM X 150MM X 150CM STERLING SL BALLOON WAS ADVANCED FOR DILATION. DURING PREPARATION, AN AIR GOT INTO THE SYRINGE WHEN NEGATIVE PRESSURE WAS PULLED. UPON FURTHER INSPECTION, IT WAS NOTED THAT THERE WAS A SMALL TEAR IN THE BALLOON. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH ANOTHER STERLING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612463 ↗
• MalfunctionMay 11, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE 70% TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS INFLATED AT 12 ATMOSPHERES FOR 2 MINUTES. HOWEVER, UPON WITHDRAWAL, THE BALLOON WAS STILL INFLATED DESPITE OF NEGATIVE PRESSURE WAS APPLIED. AFTER ABOUT 2 MINUTES OF VIGOROUS PULL, THE DEVICE WAS REMOVED FROM THE PATIENT INTACT WHILE STILL INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914992 ↗
• MalfunctionApr 10, 2023Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BALLOON RUPTURE AND MARKER BAND ISSUE OCCURRED. THE PATIENT UNDERWENT POPLITEAL ARTERY STENT PLACEMENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED POPLITEAL ARTERY IN THE RIGHT LOWER LIMB. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING BALLOON INTRODUCTION, THREE MARKERS WERE FOUND UNDER FLUOROSCOPY, AND IT WAS THEN CONFIRMED THAT THE BALLOON BURST DURING WITHDRAWAL. THE DEVICE WAS REMOVED COMPLETELY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709430 ↗
• MalfunctionMar 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN OCCLUDED VESSEL BELOW THE LEFT KNEE. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE BALLOON RUPTURED AFTER TAKING IT OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934325 ↗
• MalfunctionNov 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LOWER EXTREMITY ARTERY. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906299 ↗
• MalfunctionJul 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AND SO INSUFFLATION WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE APPROXIMATELY 40% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. ON THE FIRST BALLOON INFLATION, THE CONTRAST "ESCAPED". THE BALLOON WAS INFLATED A SECOND TIME AT 12 ATMOSPHERES FOR 20 SECONDS WHICH THE CONTRAST DID NOT COMPLETELY FILL THE BALLOON. THE DEVICE WAS REMOVED AND TESTED OUTSIDE THE PATIENT AND THE HOLE IN THE BALLOON WAS NOTED. THE PATIENT'S STATUS POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10239721 ↗