Reported Jan 9, 2013 · Terminated

Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2…

SynCardia Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SynCardia Systems Inc. · 1992 E Silverlake Rd · Tucson, AZ · 85713-3865

Is this the product you have?

Companion External Battery
Part Number293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure

Lot codes and dates: Serial # Lot#
162 of 162 codes
00067
11/12
00071
11/12
00073
11/12
00076
11/12
00079
11/12
00085
11/12
00086
11/12
00087
11/12
00089
28/12
00091
28/12
00092
28/12
00093
28/12
00094
28/12
00095
28/12
00098
28/12
00099
28/12
00101
28/12
00102
28/12
00103
28/12
00104
28/12
00105
28/12
00106
28/12
00107
28/12
00108
28/12
00109
28/12
00110
28/12
00111
28/12
00112
28/12
00113
28/12
00114
28/12
Amount recalled: 81 units

Where it was sold

Nationwide

Why it was recalled

Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.

This product could cause temporary or reversible health problems — stop using it.

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