Emerge™ H7493919108120Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729807094), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2022Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-NOV-2022. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED THIRD TIMES WITH 5 SECONDS EACH INFLATION, HOWEVER, THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915530 ↗
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- 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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