Devices

Guidant CONTAK RENEWAL 3 RF & 4 RF

Model / Serial
Model H210, serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525. Model H215, serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425. Model H217, serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350. Model H219, serial numbers: 203320, 203344, 203355, 203377, 203382. Model H230, serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155. Model H239, serial numbers: 650451, 650453, 650454.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, United Kingdom.
Product Description
Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Manufacturer
Guidant Corporation
1 Event
- Recall of Guidant CONTAK RENEWAL 3 RF & 4 RF

Manufacturer

Guidant Corporation

Manufacturer Address
Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA

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