SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA

Reason: 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.

Code information: Lot Numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, 1716500018

Distribution pattern: Nationwide