| Date Initiated by Firm |
December 05, 2012 |
| Date Posted |
December 28, 2012 |
| Recall Status1 |
Terminated 3 on June 07, 2013 |
| Recall Number |
Z-0620-2013 |
| Recall Event ID |
63915 |
| PMA Number |
P030011 |
| Product Classification |
pacemaker battery - Product Code DSZ
|
| Product |
Companion External Battery, Part Number: 293001-001
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. |
| Code Information |
Serial # Lot# 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 00115 28/12 00116 28/12 00117 28/12 00118 28/12 00119 28/12 00120 28/12 00121 28/12 00122 28/12 00123 28/12 00124 28/12 00125 28/12 00126 28/12 00127 28/12 00128 28/12 00129 28/12 00130 28/12 00131 28/12 00132 28/12 00133 28/12 00134 28/12 00135 28/12 00136 28/12 00137 28/12 00138 28/12 00139 28/12 00140 28/12 00141 28/12 00142 28/12 00143 28/12 00144 28/12 00145 28/12 00146 28/12 00147 28/12 00148 28/12 00068 11/12 00069 11/12 00070 11/12 00072 11/12 00075 11/12 00077 11/12 00078 11/12 00080 11/12 00081 11/12 00082 11/12 00083 11/12 00084 11/12 00088 11/12 00090 28/12 00096 28/12 00097 28/12 00100 28/12 |
Recalling Firm/
Manufacturer |
SynCardia Systems Inc.
1992 E Silverlake Rd
Tucson AZ 85713-3865
|
| For Additional Information Contact |
520-545-1234
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Process control |
| Action |
Syncardia Systems sent a" Urgent Field Safety Notice" dated December 10, 2012, to all affected customers. The letter identified the product the problem and what action the customer needs to take..
The letter informed the customers that there were 3 reported thermal battery events (2 of which occurred on-site at either SynCardia or at the battery manufacturer, Dow Kokam, and one incident that occurred in the field) which caused physical damage to the batteries including burning and/or charring. The batteries were not in use with a patient at time of the reported issue, and there were no reports of any adverse impact to any patient or user.
Customers are instructed to follow the directions on the attached Return page, and return their customer response form to SynCardia as soon as possible.
Customers with questions are instructed to call (520) 545-1234 or (520) 440-7593. |
| Quantity in Commerce |
81 units |
| Distribution |
Worldwide Distribution -- US (nationwide) |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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