Boston Scientific CRM Corp: 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.

Recall number

Z-1297-06

Recalling firm

Boston Scientific CRM Corp

Product

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.

Status

Terminated

Initiated

2006-06-24

Posted

2006-09-28

Terminated

2008-03-02

Reason

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.

Root cause

Other

Action

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.

Quantity

175

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, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P960040"]

Product code

KRG

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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