NC Emerge® H7493926708300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729846260), received between Sep 10, 2018 and Nov 26, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AT 20 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A 3.0 X 6MM NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780421 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. AFTER A STENT WAS PLACED, A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, WHILE ADVANCING THE BALLOON, THE SHAFT BROKE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576183 ↗
• MalfunctionOct 27, 2023

  ELDERLY MALE WITH HISTORY OF SEVERE LAD (LEFT ANTERIOR DESCENDING ARTERY) DISEASE AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATHETERIZATION AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH STENT. THE EMERGE BALLOON COULD NOT LOAD ONTO THE WIRE. A NEW EMERGE USED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, NC EMERGE (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020183 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27OCT2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS KINKED AT ABOUT 15 CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845135 ↗
• MalfunctionNov 4, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN OBTUSE MARGINAL 3 ARTERY. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE MIDWAY. THE BALLOON PARTS WERE REMOVED SUCCESSFULLY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273460 ↗
• InjuryMar 14, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE SHAFT WAS BROKEN 20CM FROM THE HUB. THE DETACHED PART WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT HARM NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420592 ↗
• MalfunctionOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INFLATION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926212 ↗
• MalfunctionSep 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL AND MID CIRCUMFLEX ARTERY. AFTER ROTABLATION WAS SUCCESSFULLY PERFORMED, A 2.5 X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PREDILATION. A 2.75 X 38MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS DEPLOYED FOR TREATMENT. AFTER STENTING, THE MID PORTION OF THE STENT NEEDED TO BE POST DILATED. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS THEN ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS USED BUT THE BALLOON ALSO RUPTURED. DURING REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE BALLOON SHEARED OFF ON THE WIRE. THE GUIDE AND WIRE WAS REMOVED, LEAVING A PORTION OF THE BALLOON IN THE PROXIMAL CIRCUMFLEX. AFTER MULTIPLE FAILED ATTEMPTS TO REMOVED IT, THE PHYSICIAN DECIDED TO STENT IT IN PLACE WITH A 3.0 X 24MM PROMUS PREMIER DES AND THE PROCEDURE WAS COMPLETED. POST PROCEDURE TIMI 3 FLOW WITH NO OBSTRUCTION WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882570 ↗
• InjurySep 10, 2018Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED, BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED AND PRE-DILATED THE LESION. AFTER STENT PLACEMENT, THE SAME BALLOON WAS USED FOR POST DILATION. HOWEVER, UPON INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED AND BECAME STUCK IN THE VESSEL. AFTER MULTIPLE REMOVAL ATTEMPTS, THEY WERE ABLE TO REMOVE IT AND WHEN THEY DID, THE BALLOON MATERIAL AND THE BALLOON MARKERS SHEARED OFF AND WERE LEFT IN THE PATIENT. A SNARING ATTEMPT WAS MADE TO RETRIEVE THE BALLOON MATERIAL THAT WAS LEFT IN THE PATIENT'S BODY BUT IT COULD NOT BE REMOVED. A COUPLE MORE STENTS WERE USED AND THEY STENTED THE MATERIAL UP AGAINST THE VESSEL WALL AND LEFT IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID FINE THROUGHOUT THE PROCEDURE AND WAS DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7860342 ↗