FDA Medical Device Recalls (openFDA)
LivaNova USA Inc.: 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.
- Recall number
- Z-1099-2019
- Recalling firm
- LivaNova USA Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-09-14
- Posted
- not on file
- Terminated
- 2022-09-14
- Reason
- For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
- Root cause
- Material/Component Contamination
- Action
- The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an "IMPORT" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email 3T.US@livanova.com. If taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process. If you have any questions, contact V.P., Clinical, Quality, and Regulatory Services at 303-467-6306 or email: joan.ceasar@livanova.com.
- Quantity
- 6 devices
- Distribution
- US Distribution to states of: IN, MO, and OH.
- Lot, serial or model codes
- Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
- 510(k) numbers
- ["K052601"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28