Impulse™ H749163911001Recalls & reported problems
Boston Scientific Corporation · Angiographic Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729344070), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- Brain Injury1
- Muscle Weakness/Atrophy1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT AN EMBOLIC STROKE OCCURRED RESULTING IN EXPRESSIVE APHASIA. ON (B)(6) 2022, AN IMPLUSE DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE. THE IMPLUSE TOOK 4 MINS TO CROSS THE VALVE. POST PROCEDURE, WITHIN THE SAME MONTH AS THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED AN EMBOLIC STROKE REQUIRING HOSPITAL TREATMENT. THE PATIENT EXPERIENCED MEMORY LOSS AND LEFT SIDE WEAKNESS POST STROKE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Brain Injury; Muscle Weakness/Atrophy; Stroke/CVA
MAUDE report 15255055 ↗
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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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