Kendall 84021BRecalls & reported problems
Cardinal Health 200, LLC · KENDALL SCD Comfort Sleeves. This product is designed for use with KENDALL SCD SMARTFLOW Controller. Knee Length Small Single Patient Use. Kit Contents: 84021 and/or 84021R. May Contain OEM and/or Reprocessed Devices. Exposed to EO Gas. Reprocessed Device for Single Patient Use Reprocessed by Sustainable Technologies. · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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.
Recalls naming this device
- May 13, 2025Completed
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1919-2025 · Root cause: Software change control · FDA record ↗
Other SLEEVE, LIMB, COMPRESSIBLE devices
- Kendall 84021Cardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE2 recalls0 reports
- Kendall SCD 29525Cardinal Health, Inc. · Sleeve, Limb, Compressible56 reports
- RAW MATERIAL 30MDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE52 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
- Kendall SCD 295251Cardinal Health, Inc. · Sleeve, Limb, Compressible24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.