Guidant Corporation CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). 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 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). 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 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319, 310320, 310321, 310322, 310343, 310353, 310355, 310381, 310383, 310386, 310387, 310388, 310389, 310390. Model H195, serial numbers: 350236, 350239, 350245, 350247, 350248, 350250, 350252, 350255, 350261, 350264, 350276, 350279, 350280, 350282, 350284, 350319, 350330, 350331, 350332, 350333, 350334, 350336, 350342, 350344, 350350, 350351, 350353, 350354, 350355, 350360, 350362, 350363, 350364, 350365, 350403, 350407, 350442, 350451, 350480, 350484, 350503, 350570, 350649. Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415, 320417, 320445.
Products Sold
Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319, 310320, 310321, 310322, 310343, 310353, 310355, 310381, 310383, 310386, 310387, 310388, 310389, 310390. Model H195, serial numbers: 350236, 350239, 350245, 350247, 350248, 350250, 350252, 350255, 350261, 350264, 350276, 350279, 350280, 350282, 350284, 350319, 350330, 350331, 350332, 350333, 350334, 350336, 350342, 350344, 350350, 350351, 350353, 350354, 350355, 350360, 350362, 350363, 350364, 350365, 350403, 350407, 350442, 350451, 350480, 350484, 350503, 350570, 350649. Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415, 320417, 320445.
Guidant Corporation is recalling CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillat due to 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 settin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026