Emerge™ H7493919115250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806820), received between Oct 18, 2019 and Feb 20, 2023 — classified as 4 malfunctions.

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

• MalfunctionFeb 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING THE PREPARATION THE BALLOON WAS NOTICED HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401942 ↗
• MalfunctionOct 8, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL ARTERY. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE GOT STUCK ON THE WIRE AND WAS UNABLE TO BE REMOVED SEPARATELY. BOTH DEVICES WERE REMOVED TOGETHER, THE BALLOON WITH THE WIRE STUCK INSIDE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649688 ↗
• MalfunctionOct 18, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. TWO 2.50 MM X 15 MM EMERGE BALLOON CATHETERS WERE USED TOGETHER WITH 2 DIFFERENT BMW WIRES CONSECUTIVELY. HOWEVER, THE BOTH DEVICES GOT STUCK WITH THE WIRES AND WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208083 ↗
• MalfunctionOct 18, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. TWO 2.50MM X 15MM EMERGE BALLOON CATHETERS WERE USED TOGETHER WITH 2 DIFFERENT BMW WIRES CONSECUTIVELY. HOWEVER, THE BOTH DEVICES GOT STUCK WITH THE WIRES AND WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED WITH NON-BSC DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208078 ↗