NA TPK1001Recalls & reported problems
Carefusion 2200, Inc · Thora-Para 8 Fr Catheter Drainage Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403076121), received between Dec 13, 2019 and Mar 10, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT UPON INSERTING THORACENTESIS/ PARACENTESIS KIT CATHETER INTO PATIENT'S PERITONEAL SPACE, THE CATHETER BEGAN TO LEAK ASCITES OUT OF THE BACK WHEN THE NEEDLE WAS REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24563589 ↗MalfunctionFeb 20, 2026
UPON INSERTING TPK CATH INTO PATIENT'S PERITONEAL SPACE, THE CATHETER BEGAN TO LEAK ASCITES OUT OF THE BACK WHEN THE NEEDLE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399815 ↗MalfunctionOct 6, 2020No Flow
INCIDENT DESCRIPTION: TPK WAS PLACED DURING A PARACENTESIS. THE TPK MALFUNCTIONED AND WOULD NOT DRAIN. THE TPK HAD TO BE REMOVED AND A NEW CATHETER HAD TO BE PLACED. THERE WERE NO COMPLICATIONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10634286 ↗MalfunctionDec 13, 2019Fluid/Blood Leak
DURING A PARACENTESIS, THE TPK CATHETER STARTED TO LEAK WHERE IT SHOULD BE LEAKPROOF. WHEN PULLING OUT THE STYLET, THE PERITONEAL FLUID LEAKS EVERYWHERE. MANUFACTURER RESPONSE FOR NEEDLE, CATHETER THORA-PARA CATHETER (PER SITE REPORTER). THEY ARE AWARE AND WILL BE DOING AN ANALYSIS OF THE RETURNED PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9465649 ↗MalfunctionDec 13, 2019Fluid/Blood Leak
DURING A PARACENTESIS, THE TPK CATHETER STARTED TO LEAK WHERE IT SHOULD BE LEAKPROOF. WHEN PULLING OUT THE STYLET, THE PERITONEAL FLUID LEAKS EVERYWHERE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9465582 ↗
Other Thoracentesis tray devices
- Safe-T-Centesis PIG1260TCarefusion 2200, Inc · Thoracentesis tray2 recalls27 reports
- Safe-T-Centesis PIG1260KCarefusion 2200, Inc · Thoracentesis tray1 recall73 reports
- NA OTP5000Carefusion 2200, Inc · Thoracentesis tray2 recalls13 reports
- Safe-T-Centesis PIG1280KCarefusion 2200, Inc · Thoracentesis tray108 reports
- NA TPT1000Carefusion 2200, Inc · Thoracentesis tray1 recall1 death19 reports
- Safe-T-Centesis PIG1280TCarefusion 2200, Inc · Thoracentesis tray1 recall8 reports
- Safe-T TPT1000SPCarefusion 2200, Inc · Thoracentesis tray1 recall6 reports
- NA TPT1005Carefusion 2200, Inc · Thoracentesis tray1 recall1 report
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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