Emerge™ Push H7493919012120Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
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 08714729805984), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionJul 30, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.20MM X 12MM EMERGE PUSH BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES IN LESS THAN 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253427 ↗
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- 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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