PVC Thoracic Catheters 8124Recalls & reported problems
Atrium Medical Corporation · 24 FR Right Angle – Soft PVC Catheter · Class 1
All models of PVC Thoracic Catheters (6)
Data updated Oct 16, 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 20650862132247), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2025Break; Break
REPORT RECEIVED STATED THAT TWO ABDOMINAL DRAINS WERE INSERTED INTRAOPERATIVELY. THE DRAINS WERE SUBSEQUENTLY REMOVED ON THE WARD. FOLLOWING REMOVAL, THE PATIENT EXPERIENCED ABDOMINAL PAIN, LEADING TO A CT INVESTIGATION. IMAGING REVEALED A PIECE OF ONE OF THE CATHETER'S WAS IN THE PATIENT.
Patient problems: Pain
MAUDE report 22294519 ↗
Other Catheter, Cholangiography devices
- PVC Thoracic Catheters 15028Atrium Medical Corporation · Catheter, Cholangiography1 recall0 reports
- Cook G08045Cook Incorporated · CATHETER, CHOLANGIOGRAPHY10 reports
- PVC Thoracic Catheters 8032Atrium Medical Corporation · Catheter, Cholangiography6 reports
- RX ERCP Cannula M00545780Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY3 reports
- Reddick Scoop Tip Cholangiogram Catheter e2401-51Lemaitre Vascular, Inc. · Catheter, Cholangiography2 reports
- Cook G03196Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- RX ERCP Cannula M00545770Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY2 reports
- Cook G02847Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
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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