Emerge™ H7493918912270Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of Emerge (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729806110), received between Sep 10, 2018 and Jun 30, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Integrity Problem1
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Patient Involvement1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT A BALLOON LEAK AND RUPTURED OCCURRED, RESULTING IN DISSECTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 2.75MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 8 ATMOSPHERES FOR 7 SECONDS, THE BALLOON LEAKED AND RUPTURED, AND A TYPE F DISSECTION WAS DETECTED IN THE VESSEL. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED BY DEPLOYING A STENT FOLLOWED BY POST DILATION WITH A 3.50 MM X 20MM NON-BOSTON SCIENTIFIC BALLOON. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 17239230 ↗MalfunctionSep 10, 2018Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem
IT WAS REPORTED THAT SHAFT HOLE/PERFORATION OCCURRED. A 2.75MM X 12MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INSPECTION, A RAISED METAL SPOT ON THE SHAFT WAS NOTED AND THE BALLOON WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7860686 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
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- 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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