PVC Thoracic Catheters 15028Recalls & reported problems
Atrium Medical Corporation · 28 FR Straight – Firm PVC Catheter · Class 1
All models of PVC Thoracic Catheters (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Apr 21, 2022Class IIOpen, Classified
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date
Z-1297-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Catheter, Cholangiography devices
- 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
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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