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.
This recall has been terminated (originally issued December 16, 2006).
- Company
- Guidant Corporation
- Recall Initiated
- September 30, 2006
- Posted
- December 16, 2006
- Terminated
- April 1, 2007
- Recall Number
- Z-0269-2007
- Quantity
- 57 (46-USA, 11 Foreign- Renewal 4RF)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.