CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
TandemLife ECLS Procedure Kit - V24/A17 recalled by Cardiac Assist
Cardiac Assist is recalling TandemLife ECLS Procedure Kit - V24/A17, distributed nationwide in the US. The recall was initiated on 19 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1106-2020
- FDA event ID
- 84611
- Recalling firm
- Cardiac Assist, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2019
- FDA classified
- 7 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 Nov 2019 | Recall initiated by company | |
| 7 Feb 2020 | Classified by FDA | +80 days |
| 19 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of AZ, AL, ME, LA, PA.
Questions about this recall
Is TandemLife ECLS Procedure Kit - V24/A17 recalled?
Yes. Cardiac Assist recalled TandemLife ECLS Procedure Kit - V24/A17 on 19 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-1106-2020.
Why was it recalled?
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of AZ, AL, ME, LA, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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