Z-1099-2019Class II

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung...

Name: Z-1099-2019 SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung...
Creator: LivaNova USA Inc.
Published: 2018-09-14
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2018-09-14 / Terminated / root cause: manufacturing process

FDA source

LivaNova USA Inc. began a recall of 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... on 2018-09-14. FDA classified it as Class II and gives the reason as "For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1099-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-14
Posted: 2019-04-06
Terminated: 2022-09-14
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.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Root cause tag: manufacturing process
FDA 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 [email protected]. 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: [email protected].
Quantity in commerce: 6 devices
Distribution: US Distribution to states of: IN, MO, and OH.
Product codes and lots: Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-05

Product code DWC

K052601Class IIStockert Heater-Cooler System 3TSorin Group Deutschland GmbH / cleared 2006-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)