Axiom® Atraum™ With ClotStop® 111120ATRecalls & reported problems
Axiom Medical, Incorporated · Thoracic Catheter, Right Angle, Silicone, With ClotStop® · Class 1
Data updated Oct 18, 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 M665111120AT0), received between Nov 22, 2021 and Nov 22, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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 18, 2026.
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2021Device Handling Problem; Device Handling Problem
CUSTOMER STATED CRYSTALLIZED MATERIAL FORMED INSIDE THE TUBE CAUSING NARROWING OF THE INNER LUMEN. CUSTOMER FLUSHED THE CATHETER WITH PLASMA-LYTE SOLUTION, PH 7.4. FOLLOWING THE FLUSH, THE PATIENT EXPERIENCED TAMPONADE. THE CUSTOMER IS CONCERNED THE CRYSTALS IN THE TUBE WERE THE CAUSE OF THE TAMPONADE.
Patient problems: Cardiac Tamponade
MAUDE report 12853799 ↗
Other Catheter, Ventricular, General & Plastic Surgery devices
- Thoracic Drain TC-xxxxxLivanova USA, Inc. · CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY5 reports
- Argyle 8888572552Cardinal Health, Inc. · CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY2 reports
- Argyle 8888572545Cardinal Health, Inc. · CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
- Argyle 8888572560Cardinal Health, Inc. · CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
- Argyle 8888573048Cardinal Health, Inc. · CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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