NC Emerge® H7493926708320Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of NC Emerge (61)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729846277), received between Feb 8, 2019 and Jan 5, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Material Deformation1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2023Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING INSERTION, THE SHAFT WAS KINKED AND WAS BROKE AT THE MIDDLE PART OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16107109 ↗MalfunctionJun 27, 2022Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.25MM X 8MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON SHAFT BROKE INTO TWO PIECES. THE DEVICE WAS NOT INSERTED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14830361 ↗MalfunctionFeb 8, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. A 3.25 X 8 NC EMERGE BALLOON WAS ADVANCED FOR TREATMENT. HOWEVER, AT 22 ATMOSPHERES THE BALLOON RUPTURED. NO PATIENT COMPLICATION INDICATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8321817 ↗
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- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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