Cardiac Assist recalls TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) due to incorrect cannula size. This kit contains a 29Fr ProtekDuo instead of the required 24Fr ProtekSolo, which could lead to improper blood flow during cardiac support procedures.
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Cardiac Assist is recalling TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) because it includes a 29Fr ProtekDuo cannula instead of the correct 24Fr ProtekSolo. This mismatch could cause improper blood flow during critical cardiac support procedures, potentially leading to complications for patients.
The kit contains a 29Fr ProtekDuo cannula instead of the required 24Fr ProtekSolo. This size mismatch could lead to improper blood flow when connected to extracorporeal circulatory support equipment, potentially causing complications during cardiac procedures.
Healthcare professionals using the TandemLife ECLS Procedure Kit V24/A17 for cardiac support. Patients receiving this equipment are at risk if the incorrect cannula causes improper blood flow during procedures.
Check for the product name 'TandemLife ECLS Procedure Kit V24/A17' with catalog number 5740-2417. The kit includes serial numbers starting with 141445 to 141454 and 141457. The expiration date for all products is August 25, 2020.
Verify the product name, catalog number, and serial numbers to confirm if your kit is affected.
The kit contains a 29Fr ProtekDuo cannula instead of the required 24Fr ProtekSolo, which could cause improper blood flow during cardiac support procedures.
The correct cannula size is 24Fr ProtekSolo, not the 29Fr ProtekDuo that is included in the recalled kit.
Check for the product name 'TandemLife ECLS Procedure Kit V24/A17' with catalog number 5740-2417 and serial numbers starting with 141445 to 141454 or 141457.
We’ve drafted a message you can send Cardiac Assist to request your refund or repair — edit it as you like.
Subject: Recall Z-1106-2020 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-1106-2020 from Cardiac Assist. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
