AngioTouch® Kit 014645Recalls & reported problems
Acist Medical Systems, Inc. · Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing · Class 2
- 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 10841716102001), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
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.
MalfunctionJan 19, 2024
PROCEDURE: LEFT HEART CATHETERIZATION. WHEN THE PACKAGE WAS OPENED FOR THE ACIST/CVI ANGIOTOUCH KIT, THERE WAS NOT A MALE ADAPTER ON BOTH ENDS. PRODUCT WAS NOT ABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542352 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.