CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199).… recallZ-0891-06 · Guidant Corporation · initiated Sep 30, 2005
Terminated All recalls posted in May 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Guidant Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0891-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 30, 2005
- Posted by the FDA
- May 23, 2006
- Recalling firm
- Guidant Corporation
- Quantity
- 70
- Product code
- NIK
- FDA submissions
- P010012
- 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.
Product description
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.
Code information (models, lots, serial 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.
Other devices under the same FDA submission
50 devices cleared under P010012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
- ACUITY™ X4 Straight 4671Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)5 deaths1,875 reports
- INOGEN™ X4 CRT-D G148Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)8 deaths1,252 reports
- RESONATE™ X4 CRT-D G447Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)13 deaths1,218 reports
- DYNAGEN™ X4 CRT-D G158Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)13 deaths1,166 reports
- MOMENTUM™ CRT-D G125Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 deaths792 reports
- MOMENTUM™ CRT-D G124Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)5 deaths790 reports
- ACUITY™ X4 Spiral L 4677Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths729 reports
- EASYTRAK® 2 IS-1 4543Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)5 deaths727 reports
- RESONATE™ HF CRT-D G547Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death542 reports
- EASYTRAK® 2 IS-1 4542Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths536 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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