Sorin Group USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2794-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA

Product Classification:

Class II

Date Initiated: June 29, 2017

Date Posted: August 9, 2017

Recall Number: Z-2794-2017

Event ID: 77810

Reason for Recall:

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot Number 1717300032

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated