CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3 recalled

Cardiac Assist is recalling TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, distributed nationwide in the US. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967

Quantity recalled46

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-1952-2020
FDA event ID: 85322
Recalling firm: Cardiac Assist, Pittsburgh, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Mar 2020
FDA classified: 11 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

6 Mar 2020	Recall initiated by company
11 May 2020	Classified by FDA	+66 days
20 May 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure to prime due to an assembly error

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Where it was distributed

US Nationwide distributions.

Nationwide

Questions about this recall

Why was it recalled?

Failure to prime due to an assembly error

Which lots are affected?

Serial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967

Where was it sold?

US Nationwide distributions.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 85322

This product is part of a recall event; the main page for the event is TandemHeart pump is assembled into kits: TandemLung Kit - DL31 recalled.

Reported	Class	Recall	Company	Reason	Where
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: TandemLung Kit - DL31 recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17 recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29 recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: TandemLife Kit Product recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD recalled	Cardiac Assist	Device Malfunction	Nationwide
20 May 2020	CLASS II	TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15 recalled	Cardiac Assist	Device Malfunction	Nationwide

More recalls from Cardiac Assist

All 14

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023Device	CLASS II	LifeSPARC Pump recalled by Cardiac Assist	Cardiac Assist	Device Malfunction	Nationwide
25 Jan 2023Device	CLASS I	Ship Kit, Lifesparc, Controller And Accessories recalled	Cardiac Assist	Device Malfunction	Nationwide
5 Oct 2022Device	CLASS I	Tandem Life LivaNova Lifesparc Controller recalled by Cardiac Assist	Cardiac Assist	Device Malfunction	Nationwide
8 Dec 2021Device	CLASS III	Ship Kit, Procedure Kit, Protekduo LS - DL31 recalled by Cardiac Assist	Cardiac Assist	Packaging Defects	4 states
5 May 2021Device	CLASS II	Protek Solo Venous Dilator Set: dilator, vessel recalled	Cardiac Assist	Packaging Defects	Nationwide

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All 6,199

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide