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U.S. Department of Health and Human Services

Class 2 Device Recall SSeries Headpiece Long Range

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  Class 2 Device Recall SSeries Headpiece Long Range see related information
Date Initiated by Firm July 24, 2008
Date Posted February 03, 2009
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0958-2009
Recall Event ID 50204
PMA Number P960058 
Product Classification cochlear implant - Product Code MCM
Product S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
Code Information a) Model AB-5301-00 (biege); Serial Numbers: 14532, 14544, 14546, 14590, 14591, 14592, 14593, 14594, 14595, 14596, 14597, 14598, 14599, 14600, 14601, 14602, 14603, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14650, 14654, 14655, 14657, 14663, 14666, 14669, 14670, 14671, 14678, 14679, 14680, 14681, 14682, 14683, 14684, 14685, 14687, 14688, 14690, 14691, 14694, 14695, 14696, 14697, 14698, 14699, 14700, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 15269, 15272, 15303, 15304, 15305, 15306, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15317, 15318, 15319, 15320, 15321, 15322, 15323, 15324, 15325, 15326, 15327, 15328, 15329, 15330, 15331, 15332, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15492, 15493, 15496, 15497, 15499, 15500, 15501, 15502 and 15504. b) Model AB-5301-10 (brown), Serial Numbers: 11112, 11113, 11114, 11115, 11121, 11123, 11124, 11125, 11126, 11129, 11160, 11161, 11163, 11164, 11165, 11166, 11167, 11169, 11170, 11171, 11172, 11173, 11174, 11175, 11176, 11177, 11178, 11179, 11180, 11181, 11182, 11183, 11184, 11185, 11186, 11188, 11189, 11190, 11191, 11196, 11201, 11208, 11215, 11216, 11217, 11218, 11250, 11251, 11254, 11255, 11256, 11257, 11259, 11260, 11261, 11262, 11263, 11265, 11267, 11269, 11270, 11271, 11272, 11273, 11274, 11275, 11277, 11278, 11280, 11281, 11282, 11283, 11284, 11285, 11286, 11287, 11288, 11289, 11290, 11291, 11292, 11293, 11294, 11295, 11296, 11297, 11298, 11299, 11300, 11301, 11302, 11303, 11304, 11305, 11306, 11307, 11308, 11309, 11324, 11325, 11326, 11327, 11328, 11329, 11330, 11331, 11332, 11333, 11334, 11406, 11413, 11414, 11416, 11418, 11430, 11432, 11435, 11437, 11438, 11439, 11443, 11445, 11446, 11449, 11452, 11453, 11454, 11499, 11501, 11508, 11510 and 11517.
Recalling Firm/
Manufacturer		 Advanced Bionics LLC
12740 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact
877-244-9541
Manufacturer Reason
for Recall		 Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can
FDA Determined
Cause 2		 Employee error
Action Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.
Quantity in Commerce Model AB-5301-00: 119 units; Model AB-5301-10: 132 units
Distribution 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.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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