Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130 Recalled by LivaNova USA Inc. Due to Incorrect labeling; it was identified that some Datapad...

Date: January 28, 2019
Company: LivaNova USA Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc. directly.

Affected Products

LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

Quantity: 5 Datapads

Why Was This Recalled?

Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.

Where Was This Sold?

This product was distributed to 2 states: CA, NJ

Affected (2 states)Not affected

About LivaNova USA Inc.

LivaNova USA Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report