Sterling® SL H74939148401010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729782551), received between Oct 17, 2019 and Jul 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUL2023. IT WAS REPORTED THAT CATHETER DIFFICULTY ADVANCING WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 4.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THERE WERE PROBLEMS WITH THE CATHETER AND ITS PROGRESS WHILE ADVANCING. THE PHYSICIAN DID NOT MEAN AND REMOVE THE BALLOON WITHOUT FURTHER PROGRESS. SUBSEQUENTLY, THE PHYSICIAN USED ANOTHER COYOTE BALLOON CATHETER AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406820 ↗
• MalfunctionOct 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220226 ↗
• MalfunctionOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MM X 100MM X 150CM STERLING SL WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED LONGITUDINALLY. THE DEVICE WAS COMPLETELY REMOVED 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 9205054 ↗