Emerge™ H7493918912400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806165), received between May 16, 2019 and Apr 18, 2024 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA USER MEDWATCH 0501160000-2024-8003 THAT THE PATIENT EXPERIENCED HYPOTENSION AND PERFORATION. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERIES, BOTH PREVIOUSLY WIRED AND STENTED. A 5.0 X 8 MM NC EMERGE BALLOON CATHETER AND A 4.00 MM X 12 MM EMERGE BALLOON CATHETER WERE SIMULTANEOUSLY INFLATED TO RECOMMENDED PRESSURES AT 18 ATMOSPHERES. HOWEVER, DURING THE PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND BOTH BALLOONS WERE DEFLATED. FOLLOWING BALLOON DEFLATION, A CONTRAST SHOT REVEALED LEFT MAIN (LM) VESSEL PERFORATION OR DISSECTION, AND BOTH BALLOONS WERE REINFLATED TO 12 ATMOSPHERES. FOLLOWING THIS TAMPONADING EFFECT BY BOTH BALLOONS, THE PERFORATION/DISSECTION OF THE LM VESSEL SEEMED TO RESOLVE AS THE STAINING HAD SIGNIFICANTLY DECREASED, AND IN THE FOLLOWING SHOTS, THE CONTRAST APPEARED TO REMAIN INSIDE THE VESSEL. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 19130405 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT IDE: IT WAS REPORTED THAT DECREASED BLOOD FLOW OCCURRED. IN (B)(6) 2022, THE SUBJECT PRESENTED WITH STABLE ANGINA. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATIONS WERE ADMINISTERED AT THE TIME OF THE INDEX PROCEDURE. A LOADING DOSE OF 324 MG OF ASPIRIN WAS GIVEN PRIOR TO THE PROCEDURE. THE TARGET LESION WAS LOCATED AT THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS PREDILATED USING A 4.0 MM X 8 MM BALLOON AND A CUTTING BALLOON WITH 90% RESIDUAL STENOSIS AND TIMI FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH 4.0 MM X 12 MM EMERGE BALLOON. FINAL ANGIOGRAPHIC RESULTS REVEALED 20% RESIDUAL STENOSIS AND TIMI FLOW OF 3. POST TREATMENT DECREASED BLOOD FLOW WAS NOTED AT THE OSTIAL DIAGONAL BRANCH. THE EVENT WAS TREATED WITH ADDITIONAL INTERVENTION USING PLAIN OLD BALLOON ANGIOPLASTY TO SUCCESSFULLY RESTORE BLOOD FLOW. THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 15755580 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED VIA FACILITY MEDWATCH # (B)(4) THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. A 4.00 MM X 12 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON ADVANCING THE DEVICE OVER THE WIRE, THE BALLOON SHAFT BROKE. THE PROCEDURE COMPLETED WITH ANOTHER 4.00 MM X 12 MM EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617772 ↗