Emerge™ Push H7493919015150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729806011), received between Nov 2, 2021 and Dec 30, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH MW5105145 THAT BALLOON DETACHMENT OCCURRED, REQUIRING SURGERY FOR REMOVAL VASCULAR PRESENTED FOR LEFT HEART CATHETERIZATION VIA THE RIGHT RADIAL ARTERY. DISEASE WAS NOTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL BRANCH. THE PHYSICIAN BALLOONED THE LAD FIVE TIMES WITH A 2.00MM X 20MM EMERGE PUSH BALLOON. THE 2.5MM X 15MM EMERGE BALLOON WAS ADVANCED WITHOUT DIFFICULTY, NO EXCESS FORCE WAS NOTED BUT WHILE MOVING INTO THE DIAGONAL, THE BALLOON DETACHED IN THE ARTERY. AN ATTEMPT WAS MADE TO SNARE THE BALLOON BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN THE GUIDE IN ORDER TO REMOVE THE DETACHED BALLOON BUT THIS WAS ALSO UNSUCCESSFUL. INADVERTENTLY THE 2.00 X 20MM EMERGE PUSH BALLOON DETACHED IN THE GUIDE IN THE RIGHT ARM. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND AN INTRA-AORTIC BALLOON PUMP WAS INSERTED IN RIGHT FEMORAL ARTERY. THE PATIENT RECEIVED TWO STENTS TO THE MID LAD AND A VENTRICULAR ASSIST DEVICE WAS INSERTED AND THEN REMOVED. THE PATIENT WAS TRANSPORTED TO A HIGHER LEVEL OF CARE FOR URGENT RETRIEVAL OF THE BALLOONS. THE PATIENT UNDERWENT VASCULAR SURGERY AND BOTH BALLOONS WERE RETRIEVED.

  Patient problems: Hematoma

  MAUDE report 13122409 ↗
• InjuryNov 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DIAGONAL BRANCH. A 1.50MM X 15MM EMERGE PUSH BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON REMOVAL OF THE DEVICE, THE SHAFT OF THE EMERGE PUSH BALLOON BROKE IN TWO AND THE DISTAL 24CM WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN TRIED TO WIRE ASIDE THE FRACTURED SHAFT AND BALLOON NEXT TO IT TO REMOVE THE DEVICE BUT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR SURGERY AND FINALLY, THE BROKEN PORTION OF THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737229 ↗