Emerge™ H7493918912220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806097), received between Mar 5, 2020 and Jan 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.25MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON DEFLATED SLOWLY. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489843 ↗
• MalfunctionOct 18, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE PACKAGING COMPROMISED OCCURRED. A 2.25MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USED. WHEN THE DEVICE WAS REMOVED FROM THE BOX, IT WAS NOTICED THAT THE LOWER EDGE OF THE DEVICE PACKAGING HAD NO SEAL TO ASSURE STERILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650523 ↗
• MalfunctionMar 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.25MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED PRIOR TO INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9801110 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID OBTUSE MARGINAL ARTERY. A 2.25MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ATTEMPTED TO CROSS THE LESION, THE BALLOON SHAFT BROKE IN HALF. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 2.5X20MM EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793572 ↗