PVC Thoracic CathetersRecalls & reported problems across all models
Atrium Medical Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PVC Thoracic Catheters model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 6 models of PVC Thoracic Catheters by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2022 and Aug 11, 2025 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PVC Thoracic Catheters recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 21, 2022Open, 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 ↗
Most reported PVC Thoracic Catheters problems
Device problems
- Inadequacy of Device Shape and/or Size5
- Break2
- Component or Accessory Incompatibility1
- Delivered as Unsterile Product1
- Fitting Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Chest Pain1
- Pain1
PVC Thoracic Catheters models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PVC Thoracic Catheters 15028Catheter, Cholangiography1 recall0 reports
- PVC Thoracic Catheters 8032Catheter, Cholangiography6 reports
- PVC Thoracic Catheters 8012Catheter, Cholangiography1 report
- PVC Thoracic Catheters 8020Catheter, Cholangiography1 report
- PVC Thoracic Catheters 8124Catheter, Cholangiography1 report
- PVC Thoracic Catheters 15024Catheter, Cholangiography1 report
Recent PVC Thoracic Catheters adverse event reports
The 10 most recent reports across all models, 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
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 ↗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 ↗MalfunctionFeb 17, 2023Break; Break
MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
MalfunctionAug 2, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
A SHIPMENT OF THORACIC CATHETERS WERE DELIVERED TO WAIKATO HOSPITAL HAD EXPIRED IN 2022. I THEN INFORMED THE CUSTOMER AND ASKED THAT THEY PULL ALL STOCK FROM THE SHELF. I WAS INFORMED THAT ONE OF THE THORACIC CATHETERS WAS USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15154090 ↗
Other Atrium Medical Corporation products
- ADVANTA SLIDER GDS51 models · 76 reports · 51 recalls
- FLIXENE SLIDER GDS17 models · 52 reports · 17 recalls
- PROLITE23 models · 515 reports
- OASIS6 models · 270 reports · 4 recalls
- PROLOOP12 models · 355 reports
- EXPRESS3 models · 142 reports · 4 recalls
- OCEAN10 models · 111 reports · 4 recalls
- iCAST29 models · 197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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