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U.S. Department of Health and Human Services

Class 2 Device Recall CONTAK RENEWAL TR and CONTAK RENEWAL TR2

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  Class 2 Device Recall CONTAK RENEWAL TR and CONTAK RENEWAL TR2 see related information
Date Initiated by Firm June 24, 2006
Date Posted September 28, 2006
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-1298-06
Recall Event ID 35754
PMA Number P030005 
Product Classification Pacemaker - Product Code NKE
Product CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.
Code Information model H120, serial numbers: 104284 thru 104291, 104311 thru 104315, 104317, 104318, 104327 thru 104332, 104335 thru 104350, 104356 thru 104363, 104366 thru 104368, 104370 thru 104376, 104378 thru 104382, 104384 thru 104386, 104388 thru 104394, 104396, 104398 thru 104427, 104430 thru 104446, 104452 thru 104524, 104526 thru 104534, 104536 thru 104538, 104540, 104542 thru 104573, 104575 thru 104578, 104580 thru 104710, 104712 thru 104716, 104718 thru 104722, 104724, 104725, 107824 thru 107827.   model H125, serial numbers: 106060, 106061, 106085, 106087 thru 106103, 106110, 106126, 106128 thru 106139, 106141 thru 106156, 106158 thru 106166, 106170 thru 106198, 106200 thru 106207, 106209, 106210, 106212 thru 106231, 106234 thru 106243, 106246 thru 106250, 106252 thru 106290, 106292 thru 106345, 106347 thru 106351, 106354 thru 106357, 106359 thru 106375.   model H140, serial numbers: 104186 thru 104188, 104237 thru 104264, 104267 thru 104282, 104284, 104286, 104288 thru 104297, 104299, 104300, 104301, 104311 thru 104320, 104357 thru 104367, 104371 thru 104403, 104405 thru 104494, 104496 thru 104519, 104522, 104525 thru 104530, 104533 thru 104544, 104551 thru 104555, 104557 thru 104575, 104578, 104579, 104581 thru 104603, 104605 thru 104615, 104617 thru 104642, 104644 thru 104646, 104648 thru 104678, 104680 thru 104708, 104710 thru 104806, 104808 thru 104824, 104826 thru 104834, 104836 thru 104894, 104896 thru 104934, 104936, 104941 thru 104943, 104949, 104950, 104952 thru 104954, 104956 thru 104961, 104963, 104964, 104966 thru 104970, 104972, 104975, 104977, 104978, 104980 thru 104982,104989 thru 105008, 105015, 105020, 105023, 105029, 105031, 105032, 107820, 107821.   model H145, serial numbers: 107684 thru 107690, 107715 thru 107743, 107748, 107751 thru 107757, 107763 thru 107771, 107791, 107792, 107809 thru 107816, 107818, 107819, 107830 thru 107847, 107849 thru 107854, 107856 thru 107860, 107862 thru 107887, 107889, 107894 thru 107899, 107902 thru 107931, 107933 thru 107985, 107990, 107996 thru 107998, 108000, 108003 thru 108074, 108076 thru 108109, 108111 thru 108154, 108156 thru 108158, 108160 thru 108167, 108169 thru 108176,108178 thru 108192, 108195, 108197, 108198, 108200, 108201, 108207.
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall		 Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion without warning in the affected devices.
FDA Determined
Cause 2		 Other
Action A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.
Quantity in Commerce 1,597
Distribution Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
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 = NKE and Original Applicant = GUIDANT CORP.
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