Aqua-Seal 8888571406 (UDI 10884521061002)Recalls & reported problems
Cardinal Health 200, LLC · Aqua-Seal Chest Drainage Unit Wet Suction, Dual Drain · Class 2
All models of Aqua-Seal (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521061002), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Decrease in Suction1
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.
MalfunctionJun 20, 2023Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED THAT THE PACU RN PAGED TO MAKE THEM AWARE THAT THE ¿SUCTION PORT WAS LOOSE AND HAD TO BE TAPED DOWN TO HOLD SUCTION¿. THIS WAS THE FIRST OCCURRENCE. THE SCRUB TECH DID NOT NOTICE ANY IRREGULARITIES/DEFECTS UPON FILLING THE SUCTION CHAMBER PRIOR TO CONNECTING THE CHEST TUBES. UPON REMOVING THE SUCTION TUBING FROM THE PORT THE NEXT MORNING (ASSESSING FOR AIR LEAK), THE PORT WAS DISLODGING AND ATTACHED TO THE SUCTION TUBING IN WHICH THE DOCTOR DECIDED TO LEAVE THE PATIENT ON WATER SEAL ONLY INSTEAD OF CHANGING THE COMPLETE SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 14JUN2023 STATED THAT THE ISSUE OCCURRED WHILE IN USE AND CAUSED DIMINISHED SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164583 ↗
Other Apparatus, Suction, Operating-Room, Wall Vacuum Powered devices
- StrykeFlow 0250070520Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 recalls250 reports
- StrykeFlow 0250070505Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571299Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- Aqua-Seal 8888571406Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- CRD 65651-517Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 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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