Z-0891-06

CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator...

Name: Z-0891-06 CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator...
Creator: Guidant Corporation
Published: 2005-09-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-09-30 / Terminated / root cause: supplier

FDA source

Guidant Corporation began a recall of CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant... on 2005-09-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0891-06
Status: Terminated
Initiated: 2005-09-30
Posted: 2006-05-23
Terminated: 2007-01-16
Recalling firm: Boston Scientific Corporation
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.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: 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 tag: supplier
FDA 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 in commerce: 70
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 codes and lots: 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.

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)