LivaNova Deutschland GmbH recall records

2 reported ongoing

3 records in this archive. Latest source date Oct 18, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender mu...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

Official source for Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
FDA device enforcement

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 ...

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

Class IIIReported terminated

Distribution: US distribution in states of FL, TX, and NE

Official source for Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) us...

Reasons in these listed records

  • Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated us...
  • The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
  • One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

These examples come from this result page and are not a ranking of every recall reason.

Checking LivaNova Deutschland GmbH

Is there a recall on livanova deutschland gmbh right now?

This archive contains 3 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking