Emerge™ H7493918930300Recalls & 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
- 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 08714729806431), received between Jun 9, 2020 and Dec 17, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem2
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED THE BALLOON DEFLATION FAILURE OCCURRED. A 3.00MM X 30MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. POST INFLATION THE BALLOON WOULD NOT DEFLATE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025178 ↗MalfunctionJun 16, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 3.5MM X 30MM EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10160002 ↗MalfunctionJun 9, 2020Deflation Problem; Deflation Problem
IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 30MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING DEFLATION OF THE BALLOON FOR REMOVAL, THE BALLOON WOULD NOT COMPLETELY DEFLATE. THE DEVICE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10132783 ↗
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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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