FDA Device recall Z-1106-2020

TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to…

• FDA Device
• Class II
• terminated
• Published 2020-02-19

On 2020-02-19 the FDA classified a Class II recall of TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to… by Cardiac Assist, citing the kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

Read the official FDA Device notice

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.

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Other recalls by Cardiac Assist

• LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000
  FDA Device · Class II · 2023-09-06 · Cardiac Assist
• SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
  FDA Device · Class I · 2023-01-25 · Cardiac Assist
• TANDEM LIFE LivaNova LIFESPARC Controller
  FDA Device · Class I · 2022-10-05 · Cardiac Assist
• SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass
  FDA Device · Class III · 2021-12-08 · Cardiac Assist
• Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization
  FDA Device · Class II · 2021-05-05 · Cardiac Assist

All Cardiac Assist recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1106-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.