PVC Thoracic Catheters 8032Recalls & reported problems
Atrium Medical Corporation · 32 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20650862130328), received between Jan 19, 2023 and Aug 11, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 reports).
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
- Inadequacy of Device Shape and/or Size5
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Chest Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD IDENTIFIED AN ISSUE WITH A RECENT BATCH OF CHEST TUBES RECEIVED. THE ENDS OF THE CHEST TUBES WERE OVAL-SHAPED ON THE DISTAL END RATHER THAN THE STANDARD ROUND SHAPE. THE OVAL SHAPE WAS NOT CONSISTENT WITH THE REQUIRED SPECIFICATIONS NEEDED FOR THE PATIENTS AND THE FACILITY WAS WERE CONCERNED ABOUT KINKING/BLOCKAGES THAT COULD OCCUR IN THE PATIENT AND AFFECT CLINICAL PERFORMANCE. NOTE: IT WAS REPORTED THIS CHEST TUBE WAS NOTICED FROM THE HOSPITAL'S INVENTORY, PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771410 ↗MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD IDENTIFIED AN ISSUE WITH A RECENT BATCH OF CHEST TUBES RECEIVED. THE ENDS OF THE CHEST TUBES WERE OVAL-SHAPED ON THE DISTAL END RATHER THAN THE STANDARD ROUND SHAPE. THE OVAL SHAPE WAS NOT CONSISTENT WITH THE REQUIRED SPECIFICATIONS NEEDED FOR THE PATIENTS AND THE FACILITY WAS WERE CONCERNED ABOUT KINKING/BLOCKAGES THAT COULD OCCUR IN THE PATIENT AND AFFECT CLINICAL PERFORMANCE. NOTE: IT WAS REPORTED THIS CHEST TUBE WAS NOTICED FROM THE HOSPITAL'S INVENTORY, PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771409 ↗MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD IDENTIFIED AN ISSUE WITH A RECENT BATCH OF CHEST TUBES RECEIVED. THE ENDS OF THE CHEST TUBES WERE OVAL-SHAPED ON THE DISTAL END RATHER THAN THE STANDARD ROUND SHAPE. THE OVAL SHAPE WAS NOT CONSISTENT WITH THE REQUIRED SPECIFICATIONS NEEDED FOR THE PATIENTS AND THE FACILITY WAS CONCERNED ABOUT KINKING/BLOCKAGES THAT COULD OCCUR IN THE PATIENT AND AFFECT CLINICAL PERFORMANCE. NOTE: IT WAS REPORTED THIS CHEST TUBE WAS NOTICED FROM THE HOSPITAL'S INVENTORY, PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771404 ↗MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
Other Catheter, Cholangiography devices
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- 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
- RX ERCP Cannula M00545770Boston Scientific Corporation · 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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