Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: VENTAK PRIZM VR model 1860 = 67; DR model 1861 = 108.
This recall has been terminated (originally issued September 28, 2006).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- June 24, 2006
- Posted
- September 28, 2006
- Terminated
- March 2, 2008
- Recall Number
- Z-1297-06
- Quantity
- 175
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion in the affected devices.
Distribution
Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
Lot / Code Info
model 1860, serial numbers: 144889, 144891, 144893 thru 144903, 144926, 144927, 144930, 144932, 144942, 144946, 144947, 144950, 144955 thru 144957, 144959, 144965 thru 144979, 144981, 144983, 144985 thru 144989, 144991, 144994, 145000 thru 145005, 145009, 145012, 145013, 145015 thru 145028, 145030 thru 145044, 145050 thru 145053, 145055, 145056, 145058 thru 145061, 145065 thru 145069, 145071 thru 145078. model 1861, serial numbers: 266473, 266475, 266477, 266478, 266480 thru 266483, 266485, 266487, 266488, 266492 thru 266494, 266496 thru 266506, 266510, 266511, 266516, 266518 thru 266521, 266523, 266525 thru 266527, 266532, 266533, 266535, 266536, 266553 thru 266557, 266561, 266576 thru 266578, 266580, 266582 thru 266587, 266608, 266617, 266632, 266637, 266641, 266663, 266665, 266668, 266671, 266676, 266684, 266685, 266694 thru 266696, 266699, 266702, 266705 thru 266712, 266714 thru 266728, 266732 thru 266741, 266744 thru 266749, 266753, 266764, 266769 thru 266775, 266777, 266779, 266780, 266782, 266784, 266786 thru 266794, 266796 thru 266798, 266802, 266803, 266805, 266807, 266812, 266820, 266823, 266824, 266829, 266832, 266833, 266835 thru 266837, 266839, 266841 thru 266843, 266849 thru 266857, 266859 thru 266863.
Root Cause
Other
Action Taken
A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.