Class 2 Device Recall Guidant RENEWAL 3 and 4 RF CRTD

• Date Initiated by Firm: March 16, 2007
• Date Posted: November 24, 2007
• Recall Status: Terminated on November 23, 2007
• Recall Number: Z-0053-2008
• Recall Event ID: 44793
• PMA Number: P010012-Rene
• Product Classification: Cardiac Resynchronization Therapy Defibrillator - Product Code LWP
• Product: Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 and M179)*. Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. (* models are not available in the USA)
• Code Information: Model M155: M155/100047, M155/100057, M155/100063, M155/100192, M155/100260, M155/100287, M155/100289, M155/100290, M155/100302, M155/100303, M155/100304, M155/100309, M155/100316, M155/100321, M155/100334, M155/100338, M155/100341, M155/100345, M155/100353, M155/100355, M155/100360, M155/100362, M155/100366, M155/100370, M155/100371, M155/100375, M155/100390, M155/100391, M155/100392, M155/100393, M155/100394, M155/100396, M155/100398, M155/100400, M155/100401, M155/100408, M155/100416, M155/100435, M155/100440, M155/100453, M155/100462, M155/100471, M155/100472, M155/100486, M155/100488, M155/100505, M155/100506, M155/100507, M155/100508, M155/100509, M155/100513, M155/100527, M155/100529, M155/100532, M155/100534, M155/100535, M155/100536, M155/100538, M155/100552, M155/100557, M155/100570, M155/100605, M155/100606, M155/100618, M155/100622 Model M159: M159/100091, M159/100097, M159/100098, M159/100103, M159/100112, M159/100120, M159/100123, M159/100130, M159/100131, M159/100139, M159/100140, M159/100148, M159/100185, M159/100187, M159/100204, M159/100213, M159/100225, M159/100250 Model M170: M170/100024, M170/100025, M170/100028, M170/100030, M170/100031, M170/100032, M170/100033, M170/100034, M170/100035, M170/100036, M170/100038, M170/100039, M170/100040, M170/100041, M170/100042, M170/100043, M170/100044, M170/100046, M170/100047, M170/100048, M170/100050, M170/100053, M170/100054, M170/100055, M170/100058, M170/100059, M170/100061, M170/100062, M170/100064, M170/100066, M170/100069, M170/100070, M170/100072, M170/100074, M170/100076, M170/100077, M170/100079, M170/100080, M170/100082, M170/100085, M170/100086, M170/100087, M170/100088, M170/100090, M170/100092, M170/100093, M170/100094, M170/100095, M170/100096, M170/100098, M170/100104, M170/100107, M170/100108, M170/100110, M170/100111, M170/100112, M170/100113, M170/100114, M170/100119, M170/100122, M170/100123, M170/100124, M170/100125, M170/100126, M170/100128, M170/100129, M170/100130, M170/100131, M170/100132, M170/100134, M170/100138, M170/100142, M170/100144, M170/100145 Model M175: M175/100012, M175/100013, M175/100014, M175/100015, M175/100018, M175/100020, M175/100022, M175/100025, M175/100026, M175/100027, M175/100029, M175/100030, M175/100031, M175/100032, M175/100033, M175/100034, M175/100036, M175/100038, M175/100039, M175/100040, M175/100042, M175/100043, M175/100045, M175/100046, M175/100047, M175/100048, M175/100049, M175/100050, M175/100051, M175/100052, M175/100054, M175/100057, M175/100058, M175/100059, M175/100061, M175/100063, M175/100064, M175/100065, M175/100067, M175/100068, M175/100069, M175/100070, M175/100071, M175/100072, M175/100073, M175/100075, M175/100076, M175/100078, M175/100079, M175/100080, M175/100081, M175/100082, M175/100083, M175/100084, M175/100085, M175/100086, M175/100093, M175/100094, M175/100095, M175/100096, M175/100097, M175/100098, M175/100099, M175/100100, M175/100101, M175/100103, M175/100107, M175/100108, M175/100109, M175/100113, M175/100115, M175/100116, M175/100118, M175/100119, M175/100120, M175/100121, M175/100124, M175/100125, M175/100127, M175/100128, M175/100129, M175/100130, M175/100131, M175/100132, M175/100133, M175/100134, M175/100138, M175/100139, M175/100140, M175/100141, M175/100144, M175/100145, M175/100148, M175/100150, M175/100152, M175/100153, M175/100156, M175/100159, M175/100160, M175/100164, M175/100166, M175/100169, M175/100173, M175/100174, M175/100177, M175/100178, M175/100179, M175/100180, M175/100181, M175/100182, M175/100183, M175/100184, M175/100186, M175/100187, M175/100188, M175/100190, M175/100191, M175/100192, M175/100193, M175/100195, M175/100196, M175/100197, M175/100198, M175/100199, M175/100200, M175/100202, M175/100203, M175/100204, M175/100206, M175/100207, M175/100209, M175/100210, M175/100211, M175/100212, M175/100213, M175/100214, M175/100215, M175/100216, M175/100219, M175/100221, M175/100222, M175/100224, M175/100228, M175/100229, M175/100230, M175/100231, M175/100232, M175/100233, M175/100234, M175/100235, M175/100237, M175/100238, M175/100239, M175/100241, M175/100244, M175/100245, M175/100247, M175/100248, M175/100249, M175/100250, M175/100251, M175/100252, M175/100256, M175/100258, M175/100259, M175/100260, M175/100262, M175/100263, M175/100264, M175/100265, M175/100266, M175/100274, M175/100294, M175/100298, M175/100299, M175/100300, M175/100303, M175/100306, M175/100308, M175/100311, M175/100322, M175/100323 Model M177: M177/100009, M177/100011, M177/100012, M177/100016, M177/100019, M177/100020, M177/100022, M177/100023, M177/100024, M177/100025, M177/100027, M177/100028, M177/100031, M177/100032, M177/100043, M177/100052, M177/100054, M177/100061, M177/100063, M177/100065, M177/100073, M177/100076, M177/100077, M177/100079, M177/100084, M177/100085, M177/100087, M177/100088, M177/100097, M177/100098, M177/100099, M177/100103, M177/100104, M177/100107, M177/100108, M177/100110, M177/100111, M177/100113, M177/100114, M177/100115, M177/100118, M177/100119, M177/100120, M177/100122, M177/100125, M177/100128, M177/100131, M177/100134, M177/100135, M177/100136, M177/100137, M177/100139, M177/100144, M177/100148, M177/100149, M177/100152, M177/100154, M177/100157, M177/100158, M177/100161, M177/100162 Model M179: M179/100008, M179/100009, M179/100010, M179/100011, M179/100014, M179/100016, M179/100018, M179/100019, M179/100020, M179/100021, M179/100022, M179/100023, M179/100024, M179/100025, M179/100026, M179/100027, M179/100028, M179/100029, M179/100030, M179/100031, M179/100032, M179/100033, M179/100034, M179/100035, M179/100036, M179/100037, M179/100038, M179/100039, M179/100040, M179/100041, M179/100042, M179/100043, M179/100044, M179/100045, M179/100046, M179/100047, M179/100049, M179/100050, M179/100051, M179/100053, M179/100054, M179/100056, M179/100057, M179/100059, M179/100061, M179/100062, M179/100064, M179/100065, M179/100066, M179/100067, M179/100069, M179/100071, M179/100075, M179/100077, M179/100078, M179/100080, M179/100081, M179/100083, M179/100085, M179/100087, M179/100090, M179/100091, M179/100092, M179/100093, M179/100095, M179/100096, M179/100097, M179/100098, M179/100099, M179/100101, M179/100103, M179/100104, M179/100107, M179/100108, M179/100110, M179/100112, M179/100113, M179/100114, M179/100116, M179/100119, M179/100120, M179/100121, M179/100123, M179/100126, M179/100129, M179/100130, M179/100131, M179/100133, M179/100134, M179/100135, M179/100137, M179/100138, M179/100139, M179/100140, M179/100142, M179/100144, M179/100145, M179/100146, M179/100147, M179/100148, M179/100149, M179/100150, M179/100152, M179/100153, M179/100155, M179/100156, M179/100157, M179/100158, M179/100160, M179/100161, M179/100162, M179/100163, M179/100165, M179/100166, M179/100167, M179/100170, M179/100171, M179/100173, M179/100177, M179/100181, M179/100183, M179/100184, M179/100185, M179/100186, M179/100187, M179/100188, M179/100189, M179/100190, M179/100191, M179/100192, M179/100193, M179/100195, M179/100196, M179/100201, M179/100203, M179/100205, M179/100207, M179/100208, M179/100209, M179/100212, M179/100215, M179/100216, M179/100217, M179/100219, M179/100222, M179/100223, M179/100227, M179/100228, M179/100229, M179/100230, M179/100231, M179/100232, M179/100233, M179/100235, M179/100237, M179/100238, M179/100239, M179/100240, M179/100243, M179/100244, M179/100247, M179/100250, M179/100253, M179/100254, M179/100256, M179/100257, M179/100259, M179/100266, M179/100270, M179/100271, M179/100272, M179/100274, M179/100275, M179/100276, M179/100278, M179/100279, M179/100280, M179/100281, M179/100282, M179/100283, M179/100285, M179/100287, M179/100290, M179/100291, M179/100293, M179/100294, M179/100295, M179/100298, M179/100300, M179/100302, M179/100304, M179/100305, M179/100307, M179/100308, M179/100309, M179/100310, M179/100311, M179/100314, M179/100315, M179/100316, M179/100317, M179/100319, M179/100321, M179/100322, M179/100323, M179/100324, M179/100325, M179/100326, M179/100327, M179/100330, M179/100331, M179/100332, M179/100334, M179/100335, M179/100336, M179/100337, M179/100338, M179/100340, M179/100342, M179/100343, M179/100344, M179/100345, M179/100346, M179/100347, M179/100348, M179/100349, M179/100350, M179/100351, M179/100352, M179/100353, M179/100354, M179/100355, M179/100356, M179/100357, M179/100358, M179/100359, M179/100371, M179/100385, M179/100386, M179/100387, M179/100391, M179/100393, M179/100395, M179/100397, M179/100399, M179/100400, M179/100401, M179/100404, M179/100405, M179/100406, M179/100407, M179/100430, M179/100431, M179/100432, M179/100433, M179/100441, M179/100442, M179/100446, M179/100448, M179/100449, M179/100452, M179/100460, M179/100467
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• Manufacturer Reason for Recall: Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product
• FDA Determined Cause: Device Design
• Action: A Product Update titled "ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge time behavior, projected rate of mid-life display of replacement indicators and Patient Management Considerations. ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only cover devices implanted prior to July 2005****
• Quantity in Commerce: 83 within USA, 580 Foreign-Recalled units only cover devices implanted prior to July 2005
• Distribution: Worldwide
• 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 = LWP and Original Applicant = Boston Scientific Corp.