NA TPT1005Recalls & reported problems
Carefusion 2200, Inc · Thora-Para 5 Fr Catheter Drainage Tray · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403220852), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2657-2020 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
MalfunctionMay 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER WOULD NOT ADVANCE OFF THE NEEDLE WITH OUT MUCH FORCE BY THE MD. WHEN HE TRIED TO LOOSEN IT THE PLASTIC CATHETER SLID OFF AND THEN WHEN IT MOVED BACK THE CATHETER TORE ON THE NEEDLE. THERE WERE NO REPORTED PATIENT INJURIES, DELAYS IN TREATMENT, OR THE NEED FOR ANY MEDICAL INTERVENTION, INCLUDING DIAGNOSTICS OR PROCEDURES. THE DEFECTIVE KIT WAS DISCARDED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22071967 ↗
Other Thoracentesis tray devices
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- 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
- Safe-T-Centesis PIG1280TSPCarefusion 2200, Inc · Thoracentesis tray1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.