Cardiac Assist recalls
Cardiac Assist appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2023-09-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2020-02-19 to 2023-09-06 |
| By agency | FDA Device (14) |
| By classification | Class II (11), Class I (2), Class III (1) |
| By status | terminated (12), ongoing (2) |
| Distribution named in notices | DC, MA, SC, US, VA |
Recalls
- 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
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, - SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
FDA Device · Class I · 2023-01-25 · Cardiac Assist
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.… - TANDEM LIFE LivaNova LIFESPARC Controller
FDA Device · Class I · 2022-10-05 · Cardiac Assist
Reason: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. - SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass
FDA Device · Class III · 2021-12-08 · Cardiac Assist
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) - Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization
FDA Device · Class II · 2021-05-05 · Cardiac Assist
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. - TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory s…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal cir…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circu…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique abil…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circul…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circula…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Reason: Failure to prime due to an assembly error - 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 · 2020-02-19 · Cardiac Assist
Reason: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.