Exact FDA event identifier

Event 82365

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: September 14, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: LivaNova USA Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1099-2019

Recall number: Z-1099-2019
Initiated: September 14, 2018
Classification: Class II
Status: Terminated
Recalling firm: LivaNova USA Inc.
Quantity: 6 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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