Cardiac Assist, Inc: TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Recall number

Z-1106-2020

Recalling firm

Cardiac Assist, Inc

Product

TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Status

Terminated

Initiated

2019-11-19

Posted

not on file

Terminated

2020-10-07

Reason

The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

Root cause

Employee error

Action

Initial communications were delivered verbally to quarantine devices starting November 19, 2019. Subsequently, on November 25, 2019 TandemLife issued Medical Device Correction notices to customers via letter 1st class mail (certified return receipt). Actions to be taken by the Customer 1. Check your inventory for the affected product listed within the notice 2. Discontinue use and Quarantine the product 2. Using the Response Form, please respond by email to USFSN@livanova.com to confirm appropriate action has been executed. 3. A replacement TandemLife ECLS Procedure Kit V24/A17 (Reference 5740-2417) has already been shipped to your facility. Your TandemLife representative will contact you to organize the collection of the affected quarantined kit(s). 4. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware. If you have transferred any affected device to a third party, please communicate this information to them and inform TandemLife Quality Assurance Team at USFSN@livanova.com. For questions regarding this Medical Device Correction, please contact your TandemLife representative, or TandemLife Customer Quality at USFSN@livanova.com.

Quantity

11 kits

Distribution

US Nationwide distribution in the states of AZ, AL, ME, LA, PA.

Lot, serial or model codes

Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445,  141446/ (01)00814112020517(17)200825(11)190423(21)00141446,  141447/ (01)00814112020517(17)200825(11)190423(21)00141447,  141448/ (01)00814112020517(17)200825(11)190423(21)00141448,  141449/ (01)00814112020517(17)200825(11)190423(21)00141449,  141450/ (01)00814112020517(17)200825(11)190423(21)00141450,  141451/ (01)00814112020517(17)200825(11)190429(21)00141451,  141452/ (01)00814112020517(17)200825(11)190429(21)00141452,  141453/ (01)00814112020517(17)200825(11)190429(21)00141453,  141454/ (01)00814112020517(17)200825(11)190429(21)00141454,  141457/ (01)00814112020517(17)200825(11)190429(21)00141457  Expiration Date for all products - August 25, 2020

510(k) numbers

["K162214"]

PMA numbers

not on file

Product code

DWF

Firm FEI

3002228812

Firm city

Pittsburgh

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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