Sterling™ H74939032300410Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729860136), received between Sep 5, 2018 and Jul 21, 2025 — classified as 2 injuries, 8 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 16, 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 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NOT TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 3.0X40X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, BALLOON BURST AT THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 22553751 ↗
• InjuryJan 5, 2024Material Rupture; Material Rupture

  MEDWATCH REPORT NUMBER: 3600840000-2023-8108. IT WAS REPORTED THAT THE BALLOON BURST REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES. A 3.0X40X150 (4F) STERLING WAS SELECTED FOR AN ANGIOPLASTY PROCEDURE AND FOR REMOVAL OF A FOREIGN BODY FROM THE LEFT COMMON ILIAC ARTERY. THE BALLOON BURST UPON REMOVAL FROM THE PATIENT. A SNARE WAS USED TO REMOVE ONE PIECE OF THE BALLOON. THE OTHER PIECE OF THE BALLOON WAS ON THE GUIDEWIRE AND PULLED INTO THE 6F SHEATH, THEN REMOVED FROM THE PATIENT. AN EXTRA PROCEDURE WAS PERFORMED, AND THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE REMOVAL OF THE 2 PORTIONS OF BALLOON WERE REMOVED DURING THE SAME PROCEDURE. THIS ADDED LONGER TIME UNDER ANESTHESIA AND THE REMOVAL OF THE 2 PARTS OF BALLOON WAS THE EXTRA PART OF THE PROCEDURE THAT WAS NOT PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459385 ↗
• InjuryDec 12, 2023

  ADULT FEMALE WITH HISTORY OF SEVERE PERIPHERAL ARTERIAL DISEASE OF BILATERAL LOWER EXTREMITIES. PROCEDURE: ANGIOPLASTY OF RIGHT AND LEFT COMMON ILIAC ARTERIES AND REMOVAL OF FOREIGN BODY FROM THE LEFT COMMON ILIAC ARTERY. THE BALLOON BURST ON REMOVAL- ONE PIECE OF THE BALLOON WAS REMOVED WITH A SNARE, THE OTHER PIECE OF BALLOON WAS ON THE WIRE WAS PULLED INTO SHEATH, THEN INTO 6 FRENCH SHEATH AND REMOVED. NO KNOWN HARM TO PATIENT AT THIS TIME. INCIDENT DID CAUSE AN EXTRA PROCEDURE, OVERNIGHT STAY FOR OBSERVATION. MANUFACTURER RESPONSE FOR CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, STERLING (PER SITE REPORTER). WILL OBTAIN, WHEN ABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309732 ↗
• MalfunctionAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 3.0X40X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438316 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON CRACKED. A 3.0X40X150 STERLING BALLOON WAS SELECTED FOR USE IN A STENOSED LESION. DURING INFLATION, THE BALLOON CRACKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509533 ↗
• MalfunctionAug 5, 2020Material Rupture

  BALLOON BURST PRIOR TO REACHING NOMINAL PRESSURE, DEVICE BARELY STARTED TO INFLATE BEFORE BURSTING. BALLOON WAS FLUSHED PER MANUFACTURE GUIDELINE. SURGEON HOOKED UP INFLATION DEVICE ONCE BALLOON WAS IN THE CORRECT LOCATION AND BEGAN TO INFLATE BALLOON, PRIOR TO REACHING NOMINAL INFLATION PRESSURE OF 6, THE BALLOON BURST. PRODUCT REMOVED, A NEW PRODUCT, SAME MANUFACTURER, WAS USED AND WORKED PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367040 ↗
• MalfunctionJul 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY. A 3.0X40X150MM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350595 ↗
• MalfunctionJan 23, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0X40X150MM STERLING BALLOON CATHETER WAS ADVANCED; HOWEVER, IT GOT STUCK ON A NON-BSC WIRE. THE ENTIRE SYSTEM WAS 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 9623146 ↗
• MalfunctionMar 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 3.0 X 40 X 150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 8402347 ↗
• MalfunctionSep 5, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 3.0 X 40 X 150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT BALLOON WOULD NOT DEFLATE TO ENABLE REMOVAL. SUBSEQUENTLY, THE BALLOON WAS REMOVED BY OVER INFLATION. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847142 ↗