Emerge™ H7493918912150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806073), received between Nov 11, 2019 and Jan 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A DEFLATION ISSUE OCCURRED. A 1.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE BALLOON EXPERIENCED DEFLATION ISSUES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489992 ↗
• MalfunctionJan 7, 2021Contamination; Contamination

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. DURING PREPARATION OF A 1.50MM X 12MM EMERGE BALLOON CATHETER, IT WAS NOTED THAT THE INNER PACKAGE WAS DAMAGED AND THERE WAS NO STERILE ENVIRONMENT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11131298 ↗
• MalfunctionNov 11, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS NOT SEALED UP. DURING PREPARATION OF A 1.50MM X 12MM EMERGE BALLOON CATHETER, IT WAS NOTICED THAT THE BOTTOM END OF THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9306366 ↗