Impulse™ H749165993010Recalls & reported problems
Boston Scientific Corporation · Angiographic Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729304920), received between Dec 17, 2018 and Jun 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. AN IMPULSE GUIDE CATHETER WAS SELECTED FOR USE. PRIOR TO PROCEDURE, WHEN THE STERILE PACKAGE WAS OPENED, IT WAS NOTED TO HAVE RIPPED AND WAS FELT TO BE UNSTERILE. A SECOND MULTIPACK WAS OPENED AND USED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT HAD NO COMPLICATIONS AND LEFT THE LAB IN GOOD CONDITION.
Patient problems: No Patient Involvement
MAUDE report 8716492 ↗MalfunctionDec 17, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS RIPPED. WHEN OPENING THE PACKAGE FOR AN IMPULSE GUIDE CATHETER, THE PACKAGE RIPPED THROUGH LOSING IT'S STERILITY. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPULSE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Patient Involvement
MAUDE report 8169408 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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