Sterling® SL H74939148401210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729782377), received between Mar 6, 2020 and Jan 22, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY TOTAL. A 4.0MM X 120MM X 150CMSTERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURSTED BEFORE IT WAS INFLATED TO NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210381 ↗
• MalfunctionMar 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION BEFORE IT REACHED THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966545 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS PULLED SLOWLY AND CAREFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436964 ↗
• MalfunctionJun 9, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON. A 4MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE IN A PERIPHERAL ANGIOPLASTY PROCEDURE. WHILE INSERTING THE DEVICE OVER THE WIRE, A HOLE IN THE BALLOON WAS OBSERVED. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967845 ↗
• MalfunctionApr 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 30% STENOSED, 100MM IN LENGTH, 4.5MM VESSEL DIAMETER, ECCENTRIC, DE NOVO, TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LOWER LEFT LIMB. THE ATHERECTOMY WAS PERFORMED WITH A JETSTREAM 2.1/3 CATHETER OVER A 14 THRUWAY GUIDE. A 4.0MM X 120MM X 150CM STERLING SL WAS FLUSHED WITH A SALINE USING 10ML SYRINGE THROUGH THE WIRE CONDUIT AND A LITTLE WATER CAME OUT OF THE DISTAL END OF CATHETER. THE BALLOON WAS THEN ADVANCED WITH A THRUWAY GUIDE 14 AND INFLATED WITH AN ENCORE 26 AT 6 AND 14 ATMOSPHERES RESPECTIVELY. HOWEVER, UPON REACHING AT 10 ATMOSPHERES INSUFFLATOR BEGAN TO DROP RAPIDLY SUSPECTED WITH A BALLOON RUPTURE. ANGIOGRAPHY SHOWS LEAKING OF CONTRAST MEDIUM INSIDE BALLOON INTO THE VESSEL. THE DEVICE WAS THEN REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THAT PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755427 ↗
• MalfunctionApr 23, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT DEFLATE. A 4.00MMX120MMX150CM STERLING SL BALLOON WAS SELECTED FOR USE IN A PROCEDURE IN THE ILIAC. AFTER THE BALLOON WAS INFLATED, IT COULD NOT BE DEFLATED. NEGATIVE PRESSURE WAS ATTEMPTED SEVERAL TIMES BUT THE BALLOON WOULD NOT ENTIRELY DEFLATE. THE BALLOON EXTENDED FROM THE PROXIMAL PORTION WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION POST-PROCEDURE WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990670 ↗
• MalfunctionMar 6, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT RADIOPAQUE MARKER BAND WAS NOT VISIBLE UNDER FLUOROSCOPY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED POPLITEAL ARTERY. A 4.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE PROXIMAL RADIOPAQUE MARKER OF THE BALLOON WAS NOT VISIBLE IN FLUOROSCOPY. 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 9800750 ↗