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Recall Observatory FDA recall evidence

Device product

S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.

Z-0142-2014

September 24, 2013

Class II

Product summary

Firm
Sorin Group Deutschland GmbH
Event
Event 66464
Status
Terminated
Classification
Class II
Quantity
84
Official record key
device-enforcement:Z-0142-2014

Official wording

Reason: Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Code information: Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801

Distribution pattern: Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.