Emerge™ H7493918915300Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729806233), received between Oct 24, 2018 and Apr 30, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (9 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-0577-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 15MM EMERGE? BALLOON CATHETER WAS USED AS A TRAPPING BALLOON INSIDE THE GUIDE CATHETER TO EXCHANGE A WIRE FOR A MICRO CATHETER OUT OF THE BODY. UPON REMOVAL OF THE BALLOON IN A DEFLATED STATE, IT WAS NOTICED THAT THE BALLOON WAS NO LONGER ON THE BALLOON CATHETER. THE GUIDEWIRE, GUIDE CATHETER, AND BOSTON SCIENTIFIC GUIDEZILLA EXTENSION CATHETER WERE PULLED OUT TOGETHER UNDER FLUOROSCOPY TO VERIFY THAT NO FOREIGN BODIES WERE LEFT IN THE PATIENT. AFTER IT WAS INSPECTED, THE WHOLE MISSING BALLOON WAS FOUND INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938291 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE SHAFT OF THE BALLOON BROKE AS THE PHYSICIAN TRIED TO INSERT IT INTO THE BODY. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS REPORTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250093 ↗
• MalfunctionMay 2, 2024Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE IT WAS NOTED THAT THE BALLOON WAS KINKED AND FAILED TO CROSS THE LESION AND THE BALLOON SHAFT BROKE. THE DEVICE WAS PULLED OUT WITH THE GUIDE EXTENSION CATHETER. A NEW DEVICE WAS USED IN REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229038 ↗
• MalfunctionMar 12, 2024Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID-RIGHT CORONARY ARTERY (RCA). A 3.00 MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE EMERGE BALLOON ADVANCED BUT FAILED TO CROSS THE LESION. AFTER A GUIDEZILLA WAS INSERTED, A BALLOON WAS REINSERTED AND INFLATED WITHOUT ISSUE. THEN, INTRAVASCULAR ULTRASOUND (IVUS) AND NON-BOSTON SCIENTIFIC (BSC) INTRAVASCULAR LITHOTRIPSY (IVL) WERE INSERTED, BUT THE DEVICES FAILED TO CROSS THE LESION. THE BALLOON WAS REINSERTED HOWEVER UNABLE TO CROSS THE LESION AND THE DEVICE GOT STUCK WITH A NON-BSC GUIDEWIRE. UPON REMOVAL, THE BALLOON AND THE NON-BSC GUIDEWIRE CAME OUT OF THE BODY TOGETHER. 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 18888248 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION, A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS BEING LOADED ONTO THE WIRE, THE BALLOON SHAFT BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144535 ↗
• MalfunctionJan 19, 2023Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2023. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 3.00MM X 15MM FG EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, THE STENT WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203406 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING PREPARATION, THE BALLOON SHAFT BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH A NEW EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762219 ↗
• MalfunctionMay 18, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A BOX LABELLED AS A 3.00MM X 15MM EMERGE HAD A 3.00MM X 15MM NC EMERGE DEVICE WITHIN THE POUCH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429544 ↗
• MalfunctionMay 18, 2022Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A BOX LABELLED AS A 3.00MM X 15MM EMERGE HAD A 3.00MM X 15MM NC EMERGE DEVICE WITHIN THE POUCH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428934 ↗
• MalfunctionApr 14, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING INSERTION, THE SHAFT OF THE BALLOON BROKE OUTSIDE OF THE BODY. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116199 ↗
• InjuryOct 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS USED FOR MULTIPLE INFLATIONS; HOWEVER, UPON ANOTHER INFLATION, A LEAK WAS NOTICED IN THE MID SHAFT. THE PATIENT BECAME SYMPTOMATIC AND A CLOT WAS NOTICED. MANUAL THROMBECTOMY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12571768 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE BALLOON WAS LOADED OVER A NON-BSC GUIDE WIRE IN A ROUGH MANNER AND THE DISTAL SHAFT WAS SNAPPED MIDWAY BETWEEN THE HUB AND THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797132 ↗
• MalfunctionFeb 17, 2021Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS EXTREMELY TIGHT IN A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION CASE. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED. ANOTHER 3.00MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION BUT IT ALSO RUPTURED DURING PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS EXTREMELY TIGHT. THE BALLOONS WERE INFLATED AT ABOUT 8 ATMOSPHERES. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A CRITICAL OSTIAL LEFT ANTERIOR DESCENDING ARTERY STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339953 ↗
• MalfunctionJan 4, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS PREPARED, HOWEVER, THE STYLET WAS STUCK DURING REMOVAL AND THE TIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS NOR HARM WERE DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11114678 ↗
• MalfunctionAug 13, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 18 ATMOSPHERSE FOR 7 SECONDS, THE BALLOON WOULD NOT STAY INFLATED. THE DEVICE WAS TAKEN OUT AND SALINE WAS FLUSHED THROUGH THE BALLOON PORT AND A PINHOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A 3.0 X 20MM EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402865 ↗
• InjuryJul 9, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DEVICE DETACHMENT OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED IN A PREVIOUSLY PLACED STENT. HOWEVER, RESISTANCE WAS FELT WHEN THE PHYSICIAN PULLED THE DEVICE BACK. WHEN THE BALLOON WAS CHECKED FOR REUSAGE, IT WAS OBSERVED THAT THE BALLOON MATERIAL WAS MISSING. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TOUGH-ANGLED TARGET LESION WAS LOCATED IN A CRUSHED STENT IN THE MID RIGHT CORONARY ARTERY. THE BALLOON MATERIAL WAS LEFT INSIDE THE PATIENT'S BODY AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10254812 ↗
• MalfunctionJan 13, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE THROMBOSED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHAFT SNAPPED IN HALF. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583079 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE BROKE WHILE INTRODUCING IT IN THE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9455568 ↗
• MalfunctionSep 16, 2019Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27AUG2019. IT WAS REPORTED THAT SHAFT BREAK OCCURRED OUTSIDE THE PATIENT'S BODY. A 3.00MM X 15MM FG EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE THE DEVICE WAS BEING LOADED OVER THE WIRE AND ADVANCED INTO THE SHEATH, THE SHAFT BROKE. THE DEVICE NEVER WENT INSIDE THE PATIENT'S BODY. THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9072444 ↗
• MalfunctionJun 7, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. A 3.00MM X 15MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, AS THE DEVICE WAS LOADED ONTO THE WIRE AND WHEN THE DEVICE ENTERED INTO THE NOSE CONE OF THE BALLOON, THE WIRE EXITED THE HYPOTUBE JUST BEYOND THE BALLOON AND MADE ITS OWN HOLE. THE WIRE NEVER ACTUALLY MADE IT TO THE MONORAIL HOLE SEGMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678066 ↗
• MalfunctionOct 24, 2018Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-OCT-2018. THIS DEVICE WAS RECEIVED WITH NO REPORTED ISSUES.   HOWEVER, UPON REVIEW OF THIS DEVICE, A PINHOLE WAS FOUND IN THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7999884 ↗