LivaNova Deutschland GmbH recalls
Every recall we track for LivaNova Deutschland GmbH — 5 in all, from 2019–2024 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
5 recalls since 2017. 40% rated “stop using now”.
All FDA recall records for LivaNova Deutschland GmbH since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled LivaNova Deutschland GmbH product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All LivaNova Deutschland GmbH recalls
4 shown- Use cautionMedical device
LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
LivaNova recalls Essenz HLM heart-lung machines with software version 1.5 due to touchscreen blackouts that may cause hypoxia. Affected units have specific serial numbers and were sold in Germany.
LivaNovaOct 18, 2024 - Lower riskMedical device
LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85
LivaNova recalls 3T Heater Cooler Systems with incorrect maintenance labeling in Quick Reference Guides. Affected units may require correction to prevent improper maintenance.
LivaNovaAug 3, 2023 - Lower riskMedical device
LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5
LivaNova recalls CP5 Drive Units (serials 60E03336-60E03347) for potential missing ferrite ring causing electrical issues in heart surgery equipment.
LivaNovaDec 17, 2021 - Stop using nowMedical device
LivaNova Deutschland GmbH recalls Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
LivaNova recalls SCP Pump Control Panel REF 60-02-15 due to potential angle encoder failure causing stroke, organ damage, or arterial injury during heart surgery. Affected units have specific serial numbers and UDI codes.
LivaNovaAug 26, 2019
LivaNova Deutschland GmbH recall questions
How many recalls has LivaNova Deutschland GmbH had?
5 recalls from LivaNova Deutschland GmbH are on record with U.S. safety agencies, from 2019–2024.
What is the most recent LivaNova Deutschland GmbH recall?
LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software, dated Oct 18, 2024. Every LivaNova Deutschland GmbH recall is listed on this page, newest first.
What should I do if I have a recalled LivaNova Deutschland GmbH product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new LivaNova Deutschland GmbH recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.