Sterling™ H74939032252210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729860075), received between Dec 26, 2019 and Oct 21, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. A 2.5X220X150 (4F) STERLING WAS SELECTED FOR ANGIOPLASTY OF THE TIBIAL ARTERY. AFTER THE BALLOON WAS INSERTED INTO THE PATIENT AND INFLATED TO TREAT THE LESION, IT WAS NOTED THAT THE BALLOON APPEARED TO BE TOO SMALL. UPON CHECKING THE SIZE LABEL ON THE STERLING HUB, IT WAS CONFIRMED THAT A 2.0X220 STERLING WAS ACTUALLY IN THE PACKAGE AND INFLATED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X220X150 STERLING DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495295 ↗
• MalfunctionJan 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. CANNULATION OF THE SUPERFICIAL FEMORAL ARTERY BY FEMORAL SHEATH 6FR WAS PERFORMED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED INTERIOR TIBIAL ARTERY. AFTER A USING 0.018 V18 GUIDEWIRE CROSSED THE LESION, A 2.5X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER INITIAL INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME BALLOON WITH SUCCESSFUL ANGIOPLASTY DONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213846 ↗
• InjuryMay 12, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 2.5X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, AFTER THE BALLOON WAS INFLATED AT 6 ATMOSPHERES, IT WOULD NOT DEFLATE. THE BALLOON WAS ATTEMPTED TO DEFLATE BY PULLING NEGATIVE PRESSURE BUT WAS UNSUCCESSFUL. THE DEVICE WAS FINALLY REMOVED WHILE IT WAS STILL INFLATED BY MANUAL EXTRACTION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL. IT WAS FURTHER REPORTED THAT THE BALLOON NEVER DEFLATED. A 50/50 SALINE-CONTRAST RATIO WAS USED. A VASCULAR SURGEON REMOVED THE BALLOON INTACT OVER THE COURSE OF FOUR HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813170 ↗
• MalfunctionMar 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER; IT WAS NOTED THAT THE CONTRAST WAS DRIPPING AT THE END OF THE BALLOON WHEN IT WAS INFLATED AS THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520775 ↗
• MalfunctionDec 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN MID TO DISTAL ANTERIOR TIBIAL ARTERY. A 2.5X220X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9522203 ↗