Kendall SCD U9525Recalls & reported problems
Cardinal Health, Inc. · Express Sequential Compression System,Vascular Refill Detection · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521100213), received between Aug 3, 2017 and Jul 9, 2018 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Temperature Problem3
- Split2
- Cut In Material1
- Thermal Decomposition of Device1
Patient problems
- No Patient Involvement3
- No Information2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2018Thermal Decomposition of Device; Temperature Problem; Temperature Problem
THE UNIT WAS RETURNED AND UPON TRIAGE IT WAS NOTED THAT THERE ARE SIGNS OF THERMAL DAMAGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7669480 ↗MalfunctionJun 4, 2018Temperature Problem; Temperature Problem
UPON TRIAGE THE SERVICE TECH FOUND THE PUMP TO HAVE THERMAL MARKS ON INSIDE OF THE UNIT BY THE BATTERY.
Patient problems: No Information
MAUDE report 7564800 ↗MalfunctionMay 31, 2018Cut In Material; Cut In Material
THE CUSTOMER REPORTS THE PUMP HAS A POWER ISSUE AND A DAMAGED POWER CORD WITH EXPOSED COPPER WIRES.
Patient problems: No Patient Involvement
MAUDE report 7556694 ↗MalfunctionMay 11, 2018Split; Split
THE CUSTOMER STATES A DAMAGED POWER CORD. UPON TRIAGE SERVICE TECHNICIANS FOUND THE WIRES TO BE EXPOSING COPPER. NO PATIENT INVOLVED OR HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508461 ↗MalfunctionNov 27, 2017Split; Split
THE UNIT WAS RETURNED WITH NO COMPLAINT LISTED. UPON TRIAGE, THE FOLLOWING ISSUE WAS FOUND: A DAMAGED POWER CORD WITH EXPOSED COPPER.
Patient problems: No Information
MAUDE report 7058946 ↗MalfunctionAug 3, 2017Temperature Problem; Temperature Problem
THE CUSTOMER REPORTS: SYSTEM ERROR. NO PATIENT INVOLVEMENT. UPON TRIAGE ON (B)(6) 2017 IT WAS NOTED BY THE SERVICE TECH THAT THERE WERE EXPOSED COPPER WIRES.
Patient problems: No Patient Involvement
MAUDE report 6763184 ↗
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- RAW MATERIAL 30MDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE52 reports
- Kendall 84021BCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- AIRCAST 3011-PLDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- Kendall 84021PCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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