Emerge™ H7493919115200Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of Emerge (54)
Data updated Oct 16, 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 08714729806806), received between Nov 7, 2018 and Feb 17, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Contamination1
- Unsealed Device Packaging1
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.
MalfunctionFeb 17, 2021Contamination; Unsealed Device Packaging
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. ON CHECKING INVENTORY, A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS NOTED TO HAVE ITS INNER PACKAGE NOT PROPERLY SEALED ALONG ONE FULL SIDE OF THE PACKAGE AND WAS COMPLETELY OPEN COMPROMISING THE STERILITY OF THE DEVICE. THE DEVICE ITSELF WAS NOT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11337623 ↗MalfunctionNov 8, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BALLOON TEAR OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS TORN WHEN CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8053354 ↗MalfunctionNov 7, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BALLOON TEAR OCCURRED. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS TORN WHEN TRYING TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8047442 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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