Emerge™ H7493918930250Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729806417), received between Mar 10, 2020 and Apr 21, 2026 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Deflation Problem; Failure to Advance

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE BALLOON DID NOT DEFLATE ENTIRELY WHEN PULLING NEGATIVE. THE BALLOON WAS PREPPED AGAIN, AND IT WOULD NOT CROSS THE LESION. THE PROCEDURE WAS THEN COMPLETED USING A DIFFERENT DEVICE, AND IT WORKED FINE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939779 ↗
• InjuryOct 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING UNEXPECTED MEDICAL INTERVENTION. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING CIRCUMFLEX CORONARY ANGIOPLASTY, THE DISTAL BALLOON CATHETER WAS COMPLETELY DETACHED AND MIGRATED INTO THE CORONARY ARTERY. THE DETACHED DEVICE REMAINED IN THE PATIENT, AND AN UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED. FURTHER DETAILS REGARDING THE INTERVENTION HAVE NOT BEEN PROVIDED. IT WAS FURTHER REPORTED THAT THE CORRECT DEVICE SIZE WAS A 2.50MM X 30MM EMERGE BALLOON CATHETER, NOT THE 2.50MM X 15MM NC EMERGE BALLOON CATHETER AS PREVIOUSLY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23200937 ↗
• DeathSep 30, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT DIED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TARGETING BOTH THE LEFT ANTERIOR DESCENDING (LAD) AND THE RIGHT CORONARY ARTERY (RCA). DURING TREATMENT OF A LONG, MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RCA, A 2.50 MM X 30 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. AT THE BEGINNING OF THE THIRD INFLATION, THE BALLOON RUPTURED AT A PRESSURE OF LESS THAN 14 ATM. FOLLOWING THE RUPTURE, NO BLOOD FLOW IN THE RCA AND THE PATIENT EXPERIENCED A BRIEF ASYSTOLIC EPISODE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, HOWEVER, ONLY THE CATHETER SHAFT WAS RETRIEVED. THE FULL 30 MM BALLOON MATERIAL REMAINED INSIDE THE PATIENT AND WAS NOT VISIBLE ON ANGIOGRAPHY. THE PHYSICIAN PROCEEDED TO PLACE STENT IN THE RCA TO RESTORE BLOOD FLOW, WHICH WAS SUCCESSFULLY RE-ESTABLISHED. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED THE SAME DAY. TWO DAYS POST-DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL IN A WORSENED CONDITION. A DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED A COMPLETE OCCLUSION OF THE RCA, WHICH COULD NOT BE RE-OPENED. THE PATIENT SUBSEQUENTLY PASSED AWAY, WITH CARDIAC FAILURE LISTED AS THE OFF

  Patient problems: Asystole; Cardiac Arrest; Foreign Body In Patient; Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 23181899 ↗
• MalfunctionJul 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225441 ↗
• MalfunctionMar 5, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS DEFLATED AND PULLED BACK BUT IT WAS STUCK IN THE LESION. IT WAS THEN NOTED THAT THE BALLOON WAS DAMAGED. THE DEVICE WAS REPLACED WITH ANOTHER UNSPECIFIED BSC BALLOON CATHETER THAT FAILED TO ADVANCE. THE PHYSICIAN REMOVED THE MARVEL GUIDEWIRE AND NOTICED A PIECE OF THE FIRST BALLOON WAS ON THE WIRE. ANOTHER WIRE WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419020 ↗
• InjurySep 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEG. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE APPROXIMATELY 135 CM FROM THE HUB. THE DEVICE WAS REMOVED THROUGH SURGERY AND THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 10576477 ↗
• MalfunctionMar 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON EDGE EXTENDED PAST THE MARKERBAND. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON- TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT 18 ATMOSPHERES, IT WAS OBSERVED THAT THE BALLOON EDGE EXTENDED WELL PAST THE MARKERBAND. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819531 ↗
• MalfunctionMar 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT RO MARKER BAND MISALIGNMENT OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, IT WAS NOTED THAT THE MARKERS ARE NOT ACCURATE AS EMERGE BALLOON EDGE EXTENDS WELL PAST MARKER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818957 ↗
• MalfunctionMar 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT RO MARKER BAND MISALIGNMENT OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, IT WAS NOTED THAT THE BALLOON MARKERS ARE NOT ACCURATE AS EMERGE BALLOON EDGE EXTENDS WELL PAST MARKER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812675 ↗