Thora-Seal 8884713308 (UDI 20884521101118)Recalls & reported problems
Cardinal Health 200, LLC · Thora-Seal Chest Drainage Unit Three Chamber System, Collection, Underwater Seal and Suction Control Chambers 2500 mL · Class 2
All models of Thora-Seal (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521101118), received between Dec 8, 2021 and Jan 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
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
- Decrease in Suction1
- Fluid/Blood Leak1
- Gas/Air Leak1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
- Unspecified Blood or Lymphatic problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2024Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED DUE TO GAS LEAKAGE, CAUSE PATIENT¿S SAFETY SERIOUSLY.ADDITIONAL INFORMATION RECEIVED STATED THE DEVICE WAS LEAKING AIR. THEY WERE UNSURE WHERE THE LEAK WAS COMING FROM. THIS WAS NOTICED AFTER USING AND THE LEAK EFFECTED THE SUCTION. THE AIR COULDN'T BE DRAINED SMOOTHLY CAUSING THE PATIENT'S BLOOD OXYGEN TO DECREASE, BUT THE HEALTHCARE PROVIDER NOTICED AND CORRECTED THE ISSUE.
Patient problems: Unspecified Blood or Lymphatic problem
MAUDE report 18464273 ↗MalfunctionJan 5, 2023Gas/Air Leak; Gas/Air Leak
THE CUSTOMER REPORTED THAT DUE TO THE BUBBLING NOTED IN THE CHEST DRAINAGE UNIT (CDU), THE PHYSICIAN ATTEMPTED TO LOCATE THE SOURCE OF AIR LEAK BUBBLING IN WATER SEAL AND SUCTION CONTROL CHAMBER WITH SUCTION REGULAR ON NOTED WHILE CHEST TUBE WAS CLAMPED. THE CUSTOMER STATED THAT A LEAK FROM PATIENT WAS RULED OUT THEREFORE THE CDU ITSELF MUST BE MALFUNCTIONING. THERE WAS NO INJURY TO THE PATIENT OR STAFF INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101764 ↗MalfunctionOct 17, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE HOSPITAL USED CHEST BOTTLE WITH OBVIOUS CREASES IN THE DRAINAGE HOSE OF THE CHEST BOTTLE, CAUSES THE DRAINAGE TO BE UNSMOOTH, CAUSING THE PATIENT¿S BLOOD OXYGEN TO DROP RAPIDLY AND STILL UNDER TREATMENT AT THE HOSPITAL. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Low Oxygen Saturation
MAUDE report 15615102 ↗MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE USER ADDED WATER FROM THE SITE OF SUCTION, THE USER FOUND THAT LEAKAGE HAPPENED FROM THE SITE OF THE WATER SEAL. NO INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12960180 ↗
Other BOTTLE, COLLECTION, VACUUM devices
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 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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