Sterling® SL H74939148308010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729782322), received between Mar 4, 2020 and Jul 7, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 3.0MM X 80MM X 150CM STERLING WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AND MATERIAL FROM THE BALLOON AND BALLOON MARKER REMAINED IN THE PATIENT. THE BALLOON MATERIAL WAS SECURED IN THE DISSECTION MEMBRANE AND FIXED WITH A STENT. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND A STENT WAS PLACED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 25738396 ↗
• MalfunctionJan 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION HAD A HARD CALCIFIC STENOSIS AND WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, AFTER INFLATING THE BALLOON FOR 3-4 TIMES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207961 ↗
• MalfunctionMar 6, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE BALLOON WAS LEAKING WATER. THE PATIENT WAS BEING TREATED FOR VASCULAR SCLEROSIS AND STENOSIS OF LOWER EXTREMITY. A 3.0MM X 80MM X 150CM STERLING SL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE BALLOON WAS INFLATED TO 5 ATMOSPHERES IT WAS NOTED THAT THE TIP WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE BALLOON IS MISSING A CHUNK 28MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844777 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR POST DILATION AFTER AN ATHERECTOMY IN A SEVERELY CALCIFIED LESION WITH A 65% STENOSIS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS, THAT THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666262 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY OR POPLITEAL ARTERY. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR LESS THAN 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664869 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY OR POPLITEAL ARTERY. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR LESS THAN 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664839 ↗
• MalfunctionAug 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON RUPTURED. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED BUT ALSO RUPTURED ON INITIAL INFLATION. THE PROCEDURE WAS CANCELED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268525 ↗
• MalfunctionDec 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

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

  MAUDE report 10959319 ↗
• MalfunctionAug 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT BELOW BURST PRESSURE THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10399744 ↗
• MalfunctionMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. ANTEROGRADE ARTERIAL ACCESS WAS PERFORMED VIA THE FEMORAL APPROACH AND TRANSPOSITION OF A SUBOCCLUSIVE LESION IN THE TIBIO-FIBULAR TRUNK TERRITORY. THE SAME WITH MULTIPLE, SEGMENTAL AND CALCIFIED STENOTIC LESIONS. AFTER A 0.018 V18 WIRE WAS PASSED THROUGH THE LESION, A 3.0MM X 80MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, BALLOON DILATION WAS UNSUCCESSFUL, WITH LOSS OF PRESSURE BEING OBSERVED IN A MANOMETER SYRINGE. LEAKAGE, PUNCTATE, WITH LEAKAGE OF INSUFFLATION FLUID AT THE DISTAL END OF THE BALLOON WAS OBSERVED. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MIDLY CALCIFIED TIBIO-FIBULAR, AND THAT THE BALLOON RUPTURED AT 6 ATMOSPHERES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786528 ↗