Every recall we track for Cardiac Assist, Inc — 14 in all — plus the complaints and injury reports the public filed about them.
Cardiac Assist recalls LifeSPARC Pumps with possible uncured epoxy that could lead to early pump failure. Affected units include specific part numbers and kit models sold between 2020-2022.
Cardiac Assist recalls LifeSPARC Controller models 5900-0000 and 5900-0001 due to software freezing and data display issues that could cause critical failure during use.
TANDEM LIFE recalls LIFESPARC Controller models 5900-0000 and 5900-0001 due to critical software freezing that may cause data loss. Affected units have specific serial numbers listed in the recall notice.
Cardiac Assist recalls specific cardiac bypass kits due to incorrect expiration date labels on packaging. Affected kits may have safety risks if used without proper expiration verification.
Cardiac Assist recalls 14 kits of Protek Solo Venous Dilator Set with incorrect packaging that could be distributed to patients. Affected units include specific catalog numbers and serial lots.
Cardiac Assist recalls TandemHeart Kit TS62/A15 (serials 00142681-00142951) due to assembly error causing failure to prime, which could lead to blood clotting risks during use.
Cardiac Assist recalls specific TandemHeart ProtekDuo Kit models (DL31 RD) due to assembly error causing failure to prime, potentially leading to inadequate circulatory support.
Cardiac Assist recalls TandemLife Kit (model 5740-0000) due to assembly error causing failure to prime. This may lead to improper blood flow during temporary circulatory support.
Cardiac Assist recalls specific TandemHeart ProtekDuo Kit models (DL3) with serial numbers 00142562-00142967 due to assembly error causing failure to prime, which may lead to inadequate circulatory support.
Cardiac Assist recalls specific TandemHeart ProtekDuo Kit models (DL29) due to assembly error causing failure to prime, potentially leading to inadequate circulatory support.
Cardiac Assist recalls specific TandemHeart Pump Kit models (serial numbers 00142577-00142961) due to assembly error causing failure to prime, which may lead to circulatory support issues.
Cardiac Assist recalls TandemHeart Kit TS62/A17 (serials 00142612-00142972) due to assembly error causing failure to prime, which may lead to inadequate circulatory support.
Cardiac Assist recalls TandemLung Kit (DL31) with serial numbers 00142473 and 00142606 due to assembly error causing failure to prime. This may lead to improper circulatory support.
Cardiac Assist recalls TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) due to incorrect cannula size. This kit contains a 29Fr ProtekDuo instead of the required 24Fr ProtekSolo, which could lead to improper blood flow during cardiac support procedures.
