PVC Thoracic Catheters 8012Recalls & reported problems
Atrium Medical Corporation · 12 FR Straight – Soft PVC Catheter · Class 1
All models of PVC Thoracic Catheters (6)
Data updated Oct 18, 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 20650862130120), received between Oct 22, 2024 and Oct 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Component or Accessory Incompatibility1
- Fitting Problem1
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.
MalfunctionOct 22, 2024Fitting Problem; Component or Accessory Incompatibility; Fitting Problem; Component or Accessory Incompatibility
WHEN USING 8012 WITH 19918 CONNECTOR - STAFF HAD TO 'STUFF' CATHETER CONNECTOR INTO CATHETER AND REALLY WORK TO GET THEM TO FIT. SAID ORIGINALLY THEY THOUGHT THE CATHETER CONNECTOR (19918) WAS TOO SMALL FOR 8012. 8012 CATHETER 'BUBBLE' IS BARELY PERCEPTIBLE OR NOT ABLE TO BE FELT AT ALL, PER STAFF. AFTER SOME STRUGGLE, WERE ABLE TO GET CATHETER ONTO FIRST RIB OF CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507611 ↗
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
- Cook G02847Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- Reddick Scoop Tip Cholangiogram Catheter e2401-51Lemaitre Vascular, Inc. · Catheter, Cholangiography2 reports
- Cook G03196Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- Fanelli G12950Cook 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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