Emerge™ H7493918930400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806479), received between Mar 27, 2020 and Apr 22, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00MM X 30MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON TRACKING THE BALLOON THROUGH THE GUIDE CATHETER, THE BALLOON POPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155021 ↗
• InjuryOct 6, 2020Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS SENT FOR SURGERY. THE TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL WAS PREPPED USING A 1.25 ROTA PRO BURR. A 4.00MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 12-14 ATMOSPHERES, THE BALLOON RUPTURED. DURING REMOVAL OF THE BALLOON, THE PHYSICIAN FELT SOME RESISTANCE. THE BALLOON PROXIMAL AND DISTAL MARKERS WERE STILL VISIBLE IN THE VESSEL AFTER REMOVING THE BALLOON CATHETER. PART OF THE BALLOON MATERIAL HAD BEEN TORN AND REMAINED IN THE VESSEL WITH THE MARKERS. THE PATIENT EXPERIENCED NO FLOW TO THE LAD. ANOTHER BALLOON WAS USED TO PLACE THE STENT WERE THE MARKERS WERE STUCK AND THE PHYSICIAN WAS ABLE TO RESTORE THE BLOOD FLOW ON THE VESSEL. HOWEVER, THE CIRCUMFLEX CORONARY ARTERY SHUT DOWN SO A ROUTINE PERCUTANEOUS CORONARY INTERVENTION TO THE VESSEL WAS PERFORMED TO RESTORE BLOOD FLOW. THE PATIENT STARTED TO CRASH SO CARDIOPULMUNARY RESUSCITATION WAS PERFORMED AND A NON-BSC DEVICE WAS INSERTED TO THE PATIENT. THE PATIENT UNDERWENT SURGERY TO THE GROIN FOR THE IMPELLA/ECMO GROIN COMPLICATIONS. NO FURTHER PATIENT COM

  Patient problems: Cardiac Arrest; Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10638018 ↗
• MalfunctionMar 27, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A LEFT CORONARY ARTERY. AFTER A 300CM NON-BSC SUPPORT GUIDEWIRE CROSSED THE LESION, A 4.00MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, THE BALLOON COULD NOT MOVE WITHOUT MOVING THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889520 ↗