ACUITY® Pro 8100Recalls & reported problems
Boston Scientific Corporation · Guide Catheter · Class 2
Data updated Oct 16, 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 08714729932420), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THIS INNER GUIDING CATHETER'S DISTAL TIP BROKE OFF UPON PULLING OUT DURING PROCEDURE. THE TIP WAS LEFT IN THE PATIENT AND THE PHYSICIAN WAS ABLE TO SNARE AND REMOVE THE TIP THROUGH THE SUPERIOR VENA CAVA. THIS CATHETER WAS USED AS IS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9592829 ↗
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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 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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