Emerge™ H7493918920150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806295), received between Oct 10, 2018 and Mar 10, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 1.50MM X 20MM EMERGE BALLOON CATHETER, IT WAS FOUND THAT THE METAL CONNECTION SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727018 ↗
• MalfunctionMar 15, 2021Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE SEGMENT OF RIGHT CORONARY ARTERY. A 1.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF A NON-BSC IMPLANTED STENT. THE EMERGE BALLOON CATHETER WAS FULLY DEFLATED PRIOR WITHDRAWAL. RESISTANCE WAS FELT DURING WITHDRAWAL AT THE LESION SITE. THE NON-BSC IMPLANTED STENT MIGRATED FROM THE TARGET LESION. ADDITIONAL STENTING WAS REQUIRED AS A RESULT OF THE MIGRATED NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483729 ↗
• MalfunctionSep 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 1.50MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN REMOVING THE DEVICE FROM THE HOOP, A KINK IN THE SHAFT WAS NOTICED AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON FURTHER, THE SHAFT FRACTURED APPROXIMATELY 25CM FROM THE HUB. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.50MM X 20MM BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10499556 ↗
• MalfunctionOct 10, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 1.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE PHYSICIAN NOTED THAT THE BALLOON AND THE CATHETER "SHREDDED" WHILE IN THE VESSEL. WHEN THE DEVICE WAS REMOVED FROM THE VESSEL TO THE GUIDE CATHETER, IT WAS NOTED THAT THE CATHETER'S EXTERNAL LAYER HAD CAME OFF AND DISLODGED INSIDE THE GUIDE CATHETER. THE PHYSICIAN USED ANOTHER BALLOON TO TRAP THE LOOSE MATERIAL IN THE GUIDE CATHETER AND THEN REMOVED EVERYTHING AS A UNIT. THE PHYSICIAN TOOK PICTURES AND CONFIRMED THAT NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS RESCHEDULED FOR LATER DATE USING ATHERECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952454 ↗