NC Emerge® H7493926712320Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729846406), received between May 22, 2019 and Oct 10, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON SHAFT BROKE INSIDE THE GUIDE CATHETER WHEN LOADING INTO THE BODY. THE DEVICE DID NOT SEPARATE COMPLETELY AND WAS SIMPLY PULLED TO REMOVE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417162 ↗
• MalfunctionOct 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS PRE-DILATED WITH A 2.50MM X 20MM NC EMERGE BALLOON CATHETER. HOWEVER, DURING THIRD INFLATION AT 18 ATMOSPHERES (ATM) FOR 20 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH ANOTHER 2.50MM X 20MM NC EMERGE BALLOON CATHETER, BUT ALSO RUPTURED DURING THIRD INFLATION AT 20 ATM FOR 20 SECONDS. AFTER BALLOONING AND STENTING THE DISTAL RCA, PRE-DILATATION WAS PERFORMED ONCE MORE WITH A 3.25MM X 12MM NC EMERGE BALLOON CATHETER BUT IT ALSO RUPTURED DURING FOURTH INFLATION AT 20 ATM FOR 20 SECONDS. A 3.0X38 SYNERGY XD WAS PLACED AND POST DILATED WITH A 3.25X12 NC EMERGE BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927499 ↗
• MalfunctionSep 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 3-4 ATMOSPHERES THE BALLOON RUPTURED DUE TO THE PINHOLE LEAKAGE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17696324 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. HOWEVER, UPON OPENING, IT WAS NOTED THAT THE BALLOON ON WIRE BROKE OFF. THE DEVICE WAS NEVER USED TO THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835687 ↗
• MalfunctionOct 6, 2022Material Puncture/Hole; Physical Resistance/Sticking; Material Puncture/Hole; Physical Resistance/Sticking

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE WIRE WOULD NOT FEED THROUGH THE BALLOON SHAFT WHEN THE BALLOON WAS TRIED TO LOAD ON THE WIRE AND A SHAFT HOLE WAS NOTED. THE DEVICE WAS REPLACED WITH A NEW NC EMERGE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554528 ↗
• MalfunctionJun 8, 2021Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE DROPPED ON THE FLOOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960718 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDE CATHETER WAS PLACED, A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON PULLING THE BALLOON OUT, THE SHAFT BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH 3.25X15MM NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532482 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 3.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT BROKE AROUND 6-8 CENTIMETERS, THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631862 ↗