NC Emerge® H7493926708450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729846314), received between Oct 17, 2018 and Jul 4, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE BALLOON RUPTURED EVEN BEFORE USING IT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674553 ↗
• InjurySep 20, 2023Break; Material Rupture; Material Deformation; Break; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A NON-BOSTON SCIENTIFIC (BSC) STENT WAS PLACED AND A 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS USED FOR POST DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON GOT STUCK INSIDE OF THE STENT WHEN TRIED TO DEFLATE AND WHEN THE BALLOON WAS RE-INFLATED AT INCREASED ATMOSPHERIC PRESSURE, THE BALLOON RUPTURED. SUBSEQUENTLY, WHEN THE SYSTEM WAS REMOVED, THE DEVICE WAS NOTED TO BE FRACTURED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN FRAGMENTS WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780478 ↗
• InjuryMay 18, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. THE 80% IN-STENT RESTENOSED (ISR) TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00MM X 10MM WOLVERINE CORONARY CUTTING BALLOON WAS INTRODUCED BUT THE LESION WOULD NOT YIELD. ROTA AND LASER CORONARY ANGIOPLASTY WERE ALSO PERFORMED BUT THE ISR STILL WOULD NOT FULLY EXPAND. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS USED NEXT BUT THE LESION STILL WOULD NOT YIELD. ANOTHER 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED AT 22 ATMOSPHERES AND AFTERWARD, THE BALLOON COULD NOT BE REMOVED. THE PHYSICIAN TRIED GOING NEUTRAL AND NEGATIVE SEVERAL TIMES. DURING AN ATTEMPT TO ADVANCE THE BALLOON AND PULL IT BACK, THE SHAFT BROKE 124 CM FROM PROXIMAL AND THE DISTAL PORTION OF THE DEVICE REMAINED STUCK IN THE LESION. ON ANGIOGRAPHY, THE BALLOON APPEARED TO STILL BE PARTIALLY INFLATED. THE PHYSICIAN ATTEMPTED TO DISLODGE THE DETACHED BALLOON BY PUTTING A WIRE AND BALLOON NEXT TO IT. THE PATIENT REMAINED STABLE WITH PART OF THE ANTERIOR WALL DEAD AND WITH SLOWING FLOW. THE PATIENT WAS SENT TO SURGERY WHERE THE BALLOON WAS REMOVED. THE PATIENT THEN UNDERW

  Patient problems: Obstruction/Occlusion

  MAUDE report 11845275 ↗
• InjuryJun 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN THE LEFT MAIN ARTERY. A 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. WHEN THE ENDOINFLATOR WENT UP, THE SHAFT BROKE. THE BALLOON HAD TO BE TRAPPED OUT BETWEEN THE GUIDE AND LEFT MAIN TO REMOVE THE DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8671804 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT NOMINAL PRESSURE, IT WAS NOTED THAT THE MID SHAFT GOT SEPARATED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628638 ↗
• InjuryOct 17, 2018Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, CATHETER REMOVAL DIFFICULTY, AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN (LM). A 4.50MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO POST DILATE A STENT. WHEN THE BALLOON WAS INFLATED BEYOND RATED BURST PRESSURE, THE BALLOON RUPTURED. THE CATHETER SHAFT WAS PULLED EXCESSIVELY IN ATTEMPT TO REMOVE THE DEVICE; HOWEVER, THE SHAFT BROKE. THE BALLOON HAD TO BE TRAPPED OUT OF THE GUIDE AND LEFT MAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED HOME AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973852 ↗