Emerge™ H7493918920300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729806349), received between May 1, 2019 and Jul 22, 2024 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) AND CIRCUMFLEX ARTERIES. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE BALLOON WAS UTILIZED TO RE-ENTER A PREVIOUSLY DEPLOYED DRUG-ELUTING STENT (DES) THROUGH THE STENT STRUTS, AFTER WHICH THE BALLOON SEPARATED FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798184 ↗
• InjuryNov 3, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, DETACHMENT AND SURGICAL INTERVENTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE, A 3.00 MM X 38 MM EMERGE BALLOON RUPTURED AND FRACTURED. FOLLOWING UNSUCCESSFUL ATTEMPTS USING SNARES AND BALLOONS, THE PATIENT REQUIRED SURGERY BYPASS TO REMOVE THE DISTAL BALLOON SEGMENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18069173 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INSERTION OF EMERGE BALLOON IN LAD TOGETHER WITH 2.5X24 SYNERGY XD STENT INTO DIAGONAL LESION, THE BALLOON SHAFT FRACTURED IN MID SECTION OF THE DEVICE. THE DEVICE WAS REMOVED AND ANOTHER 3.00MM X 20MM EMERGE BALLOON WAS USED BUT THE BALLOON SHAFT WAS BENT. THE DEVICE WAS ALSO REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE INTO TWO PIECES. THE DEVICE WAS STILL OUTSIDE THE GUIDE WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726406 ↗
• MalfunctionMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SHEARED OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600299 ↗
• InjuryOct 3, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING AN ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY (RCA). A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS INSERTED AND INFLATED. HOWEVER, WHEN ANOTHER BALLOON WAS INSERTED TO FOLLOW UP, IT WAS NOTICED THAT THE SHAFT BROKE OFF IN THE MID RCA AND LODGED IN THE ARTERY. PHYSICIAN TRIED TO RETRIEVE THE BALLOON BUT WAS UNSUCCESSFUL. PATIENT BRADYCARDIA WITH COMPRESSIONS AND PATIENT RECEIVED ADDITIONAL RADIATION EXPOSURE. A COVERED STENT AND A DRUG-ELUTING STENT WERE THEN PLACED TO SECURE BROKEN PIECE AGAINST THE WALL OF THE ARTERY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Bradycardia; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15531829 ↗
• MalfunctionSep 22, 2022Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED TO TREAT THE LESION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON BUT WAS NOT SUCCESSFUL. UPON REMOVAL, IT WAS NOTICED THE MID SHAFT OF THE BALLOON WAS FRACTURED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463236 ↗
• MalfunctionJul 18, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT LABELLING ISSUE WAS ENCOUNTERED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE BOX, IT WAS NOTED THAT THERE WAS ACTUALLY A 3.00 X 20 NC EMERGE BALLOON INSIDE. THE NC BALLOON WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15046883 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE WHEN IT WAS LOADED OVER THE WIRE. THE BROKEN SHAFT WAS OUTSIDE THE BODY. THE DEVICE WAS REMOVED SINCE IT WAS NOT FULLY INSERTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 20 EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588923 ↗
• InjuryJul 9, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA FACILITY MEDWATCH# 5101717 THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). DURING A CASE INVOLVING A 3.00MM X 20MM EMERGE BALLOON CATHETER, THE BALLOON BECAME STUCK IN THE RCA AND MULTIPLE UNSUCCESSFUL REMOVAL ATTEMPTS WERE MADE. THE PHYSICIAN CONSULTED WITH SURGERY TO BE ON STANDBY SO THAT ENOUGH PRESSURE COULD BE APPLIED TO REMOVE THE BALLOON. DURING REMOVAL, A PORTION OF THE DEVICE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12143148 ↗
• InjuryJun 22, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTIES WERE REPORTED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER ATHRECTOMY PROCEDURE, THE BALLOON WAS STUCK. IT WAS ATTEMPTED TO RE-INFLATE AND DEFLATE WITH A GUIDE CATHETER BUT FAILED TO RETRIEVE THE BALLOON. IT WAS NOTED THAT THE CATHETER WAS AGGRESSIVELY PULLED, BREAKING THE BALLOON AND LEAVING A PART IN THE RCA. IT WAS DECIDED TO LEAVE THE PART IN THE PATIENT'S BODY AS NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12044855 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A NON-CALCIFIED CIRCUMFLEX ARTERY WHICH HAD AN ANGULATED TAKE OFF. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS INTRODUCED FOR DILATATION. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE BALLOON AND AFTER A LOT OF STRUGGLING, THE BALLOON SHAFT WAS BROKE ABOUT 1/3 OF THE WAY FROM THE HUB, OUTSIDE OF THE BODY. A NON-BOSTON SCIENTIFIC (BSC) BALLOON WAS USED NEXT WITH THE AID OF A GUIDEZILLA EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH BSC BALLOONS. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610654 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED, THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, THE BALLOON BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441005 ↗
• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, THE MID SHAFT OF THE BALLOON BROKE WHILE ADVANCING THROUGH THE GUIDE. THE DEVICE WAS COMPLETELY REMOVED BY PULLING OFF THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734052 ↗
• MalfunctionAug 13, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, THE BALLOON BECAME STUCK IN THE BMW GUIDE WIRE. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT'S BODY AND WHEN TRIED TO REMOVE THE BALLOON FROM THE WIRE, THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401177 ↗
• InjuryJul 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CAROTID VESSEL. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON GOT SEPARATED FROM THE DELIVERY SYSTEM AND LEFT A PORTION OF BALLOON MATERIAL IN THE PATIENT'S CAROTID ARTERY. THERE WERE MULTIPLE ATTEMPTS TO RETRIEVE THE DETACHED COMPONENT WITH A SNARE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10330692 ↗
• MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION OF AN IN-STENT LESION. HOWEVER, DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON WAS DETACHED FROM THE SHAFT OF THE SYSTEM. THE BALLOON MATERIAL WAS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637493 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FO USE. HOWEVER, THE BALLOON BROKE AND HAD TO BE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9206004 ↗
• InjuryMay 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE BALLOON FAILED TO INFLATE. AN ATTEMPT TO REMOVE THE DEVICE WAS MADE AND FOUND THE SHAFT BROKEN. THE DEVICE CANNOT BE PULLED OUT INITIALLY AND WAS THEN REMOVED BY INFLATING ANOTHER BALLOON BEHIND IT WHILE PULLING IT OUT. 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 8568673 ↗