Guidant Corporation: CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.

Recall number

Z-0890-06

Recalling firm

Guidant Corporation

Product

CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.

Status

Terminated

Initiated

2005-09-30

Posted

2006-05-23

Terminated

2007-01-16

Reason

Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.

Root cause

Other

Action

Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians. The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which they tried to induce the failure. The results of the testing induced 2 battery weld post failures. A projected rate of occurence was also given. Patient management recommendations have not changed.

Quantity

180

Distribution

Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI). OUS to include: Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, United Kingdom.

Lot, serial or model codes

Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666, 360714, 360719, 360721, 360738,  360741, 360742, 360743, 360745, 360746, 360749, 360756,  360758, 360763, 360766, 360790, 360791, 360792, 360796,  360800, 360802, 360844, 360847, 360848, 360861, 360863,  360904, 360907, 360908, 360910, 360986, 360987, 360988,  360989, 360991.  Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537, 310544, 310545, 310706, 310707,  310709, 310713, 310719, 310721, 310734, 310735, 310737,  310746, 310753, 310796, 310798, 310813, 310907, 310908,  310909, 310913, 310916, 310976, 310990, 310996, 311007,  311010, 311011, 311013, 311015, 311016, 311092, 311096,  311152, 311154, 311181, 311185, 311386, 311389.   Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021, 281022, 281024, 281045, 281056,  281066, 28107, 281077, 281119, 281121, 281123, 281124,  281126, 281127, 281143, 281175, 281213, 281233, 281247,  281320, 281356, 281364, 281368, 281371, 281376, 281385,  281401, 281403, 281413, 281476, 281480, 281484, 281485,  281491, 281533, 281539, 281542, 281544, 281559, 281562,  281580.   Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954, 110955, 110958, 110980, 110983,  110987, 110988, 111000, 111001, 111003, 111004, 111007,  111012, 111024, 111041, 111042, 111128, 111173, 111180,  111198, 111201, 111248, 111250, 111254, 111263, 111294,  111299, 111308, 111313, 111334, 111335, 111336, 111338,  111340, 111341, 111342, 111346, 111350, 111352, 111390,  111391, 111392, 111393, 111397, 111422.

510(k) numbers

not on file

PMA numbers

["P010012S008"]

Product code

NIK

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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