NC Emerge® H7493926708350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729846284), received between Oct 13, 2021 and Feb 19, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Class IITerminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0579-2020 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryFeb 19, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE IN-STENT RESTENOSIS LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. A PROLONGED HIGH-PRESSURE INFLATION WAS PERFORMED AND THE BALLOON RUPTURED. THERE WAS DIFFICULTY RETRIEVING THE BALLOON INTO THE NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. A GUIDE EXTENSION WAS ADVANCED OVER THE BALLOON TO REMOVE THE BALLOON, GUIDEWIRE, AND NON-BSC GUIDE CATHETER AS ONE UNIT. HOWEVER, THIS LED TO BALLOON AVULSION OFF OF THE SHAFT OF THE BALLOON DELIVERY SYSTEM. THE BALLOON FRAGMENT SEEN IN THE PROXIMAL RCA STENT SEGMENT. SNARING WAS ATTEMPTED USING A 2-WIRE TWIST TECHNIQUE WITH NEW GUIDEWIRES BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO SUCTION THE REMAINING FRAGMENT USING A NON-BSC DEVICE, BUT IT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN THEN USED A 1.5 X 12 MM NON-BSC BALLOON CATHETER TO PULL IT BACK INTO THE GUIDE, BUT THIS ONLY MOVED A SEGMENT OF THE BALLOON FROM THE PROXIMAL SEGMENT TO THE MID-SEGMENT, AS COULD BE SEEN BY THE BALLOON MARKERS. SHORTLY AFTER, THE PHYSICIAN DECIDED THAT THE BEST OPTION

  Patient problems: Foreign Body In Patient

  MAUDE report 21417333 ↗
• MalfunctionMar 6, 2024Nonstandard Device; Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.50MM X 8MM FG NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON BURST. THE BALLOON WAS REMOVED AND COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849933 ↗
• InjuryOct 13, 2021Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, BALLOON DETACHMENT, AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED AFTER INFLATION AND CAME OFF THE RAIL SYSTEM. IT WAS ALSO NOTED THAT THE SHAFT FRACTURED. THE PHYSICIAN REMOVED THE BALLOON INTACT VIA A GOOSENECK SNARE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625017 ↗