LivaNova USA Inc.: Medical Device Recall in 2019 - (Recall #: Z-1099-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Product Classification:

Class II

Date Initiated: September 14, 2018

Date Posted: April 17, 2019

Recall Number: Z-1099-2019

Event ID: 82365

Reason for Recall:

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

Status: Terminated

Product Quantity: 6 devices

Code Information:

Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

Distribution Pattern:

US Distribution to states of: IN, MO, and OH.

Voluntary or Mandated:

Voluntary: Firm initiated