Emerge™ H7493919112250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806714), received between Jun 6, 2019 and Dec 27, 2023 — 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 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.

• MalfunctionDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DESPITE APPLICATION OF PRESSURE, THE BALLOON COULD NOT BE INFLATED; AND A VISIBLE PINHOLE WAS OBSERVED ON THE BALLOON MATERIAL. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18403356 ↗
• MalfunctionOct 29, 2019Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT INNER PACKAGING UNSEALED OCCURRED. UPON OPENING THE BOX OF A 2.50MM X 12MM EMERGE BALLOON CATHETER, IT WAS NOTED THAT THE INNER PACKAGING HAD NOT BEEN SEALED, LEAVING THE BALLOON UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9253099 ↗
• MalfunctionJun 6, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON CATHETER WAS BACKLOADED ON THE GUIDEWIRE, THE GUIDEWIRE POKED OUT OF THE SIDE OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677121 ↗