Z-1917-2025Class II

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD...

Name: Z-1917-2025 SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD...
Creator: Cardinal Health 200, LLC
Published: 2025-05-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-05-13 / Completed / root cause: software

FDA source

Cardinal Health 200, LLC began a recall of SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller on 2025-05-13. FDA classified it as Class II and gives the reason as "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1917-2025
Classification: Class II
Status: Completed
Initiated: 2025-05-13
Posted: 2025-06-06
Recalling firm: Medtronic, Inc.
Product: SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Root cause tag: software
FDA root cause: Software change control
Action: On May 13, 2025, the firm began to notify customers via Urgent Medical Device Product Correction letters. Customers were informed of the issue, which exclusively impacts use of the Comfort Small Knee Sleeve. Other sleeve sizes are unaffected and operate as intended with the SmartFlow Controller. The product remains operational if the Comfort Small Knee Sleeve and SmartFlow Controller configuration is not utilized during therapy. A software update on the SmartFlow Controller is necessary before using the SmartFlow controller with the Comfort Small Knee sleeve configuration. Customers should discontinue use of the Comfort Small Knee Sleeve with the SmartFlow Controller and utilize a suitable alternative such as SM thigh or foot cuff. Customer service representatives will coordinate with customers to facilitate a software update which will allow the controllers to be utilized with the small knee sleeves without causing the error.
Quantity in commerce: 6517 cases total
Distribution: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Product codes and lots: UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1917-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1917-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-18	2025-06-06
Z-1918-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-18	2025-06-06
Z-1919-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code JOW

K230028Class IIKendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyCardinal Health200, LLC / cleared 2023-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)