NC Emerge® H7493926706400Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729846192), received between Sep 11, 2018 and Jul 24, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED LESION. A 4.00MM X 6MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, THE SHAFT BROKE IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10323140 ↗MalfunctionSep 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE. IT WAS NOTED DURING PREPARATION TO POST DILATE THAT THE 4.00MM X 6.00MM NC EMERGE BALLOON WAS OPENED AND THE TAG ON THE HUB OF THE DEVICE SAID IT WAS A 3.00MM X 8.00MM. THE BALLOON WAS NOT USED AND NEVER ENTERED THE PATIENT AS THE ISSUE WAS FOUND DURING UNPACKING.
Patient problems: No Patient Involvement
MAUDE report 7866412 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
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- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- 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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