Exact FDA event identifier

Event 89312

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

Open FDA event record

Event summary

Timeline bucket: December 17, 2021
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: LivaNova Deutschland GmbH

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 Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

Z-0787-2022

Recall number: Z-0787-2022
Initiated: December 17, 2021
Classification: Class III
Status: Terminated
Recalling firm: LivaNova Deutschland GmbH
Quantity: 4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

Code information

CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347

Distribution pattern

US distribution in states of FL, TX, and NE