FLEX ADVANTAGE 65651-930CRecalls & reported problems
Cardinal Health 200, LLC · Flex Advantage 3000cc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50885380028944), received between Jan 3, 2017 and Nov 12, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.
Most reported problems
Device problems
- Activation Problem1
- Air Leak1
- Collapse1
- Detachment Of Device Component1
- Device Operates Differently Than Expected1
- Fluid/Blood Leak1
- Suction Failure1
Patient problems
- Injury1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2020Collapse; Suction Failure; Activation Problem
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE DISPOSABLE FLEXIBLE LINER REPORTEDLY COLLAPSED, ACTIVATED THE FILTER, AND DID NOT SUCTION. THE LINER WAS DISCARDED.
Patient problems: Insufficient Information
MAUDE report 10828539 ↗MalfunctionJan 3, 2017Air Leak; Detachment Of Device Component; Fluid/Blood Leak; Device Operates Differently Than Expected
CUSTOMER STATES LINER IS FILLING UP WITH FOAM AS SOON AS AROUND 200 CC DURING PARACENTESIS CASE. TUBING POPPED OFF AND EMPLOYEE SPRAYED IN FACE WITH CONTENTS. .
Patient problems: Injury
MAUDE report 6217780 ↗
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 8888571406Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571489Cardinal 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
- CRD 65651-510Cardinal 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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