Overview of recall records associated with Cardiac Assist, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 10, Class III: 1, Class I: 1.
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
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…
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…
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…
Failure to prime due to an assembly error
Failure to prime due to an assembly error
Failure to prime due to an assembly error
Failure to prime due to an assembly error
Failure to prime due to an assembly error
Failure to prime due to an assembly error
Failure to prime due to an assembly error
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
This page summarizes recall records in which the official source identifies Cardiac Assist, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
