Guidant Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Guidant Corporation is recalling Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK due to Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no ene. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
Recommended Action
Per FDA guidance
An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.
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 noticeDistribution
As reported by FDA
CA, FL, GA, IL, IA, KY, MA, MO, NJ, NY, OH, PA, TX
Page updated: Jan 10, 2026