Pittsburgh, PA, United States
Cardiac Assist, Inc recalls
7 recalls recorded since 2018, most recently on 30 June 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 30 June 2023
- Reason
- Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- Distribution
- US Nationwide distribution in the states of IL, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2465-2023
- LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit number
Terminated Class I Medical devices
- Recall started
- 5 December 2022
- Terminated
- 8 August 2023
- Reason
- A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0926-2023
- SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Terminated Class I Medical devices
- Recall started
- 21 July 2022
- Terminated
- 8 August 2023
- Reason
- Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1763-2022
- TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Ongoing Class III Medical devices
- Recall started
- 14 October 2021
- Reason
- Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
- Distribution
- US Distribution to states of: DC, MA, SC, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0311-2022
- SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHe
Terminated Class II Medical devices
- Recall started
- 19 March 2021
- Terminated
- 22 November 2021
- Reason
- On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
- Distribution
- US Nationwide distribution in the states of AL, AZ, IL, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1486-2021
- Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - Tandem
Terminated Class II Medical devices
- Recall started
- 6 March 2020
- Terminated
- 20 November 2020
- Reason
- Failure to prime due to an assembly error
- Distribution
- US Nationwide distributions.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1954-2020, Z-1950-2020, Z-1948-2020, Z-1951-2020, Z-1952-2020, Z-1955-2020, Z-1953-2020, Z-1949-2020
- TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagula
- TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an antico
- TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
- TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulan
- 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 anticoagulan
- TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant thr
- TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagu
- TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoa
Terminated Class II Medical devices
- Recall started
- 19 November 2019
- Terminated
- 7 October 2020
- Reason
- The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
- Distribution
- US Nationwide distribution in the states of AZ, AL, ME, LA, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 provide a conduit for blood to travel from the patient s venous system when con
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.