Company:Guidant Corp-Cpi Division.
Date of Enforcement Report: 6/11/03
Class: II
PRODUCT
a) Pulsar Multiprogrammable Pacemaker, DDD Model 970.
Recall # Z-0875-03;
b) Pulsar Multiprogrammable Pacemaker, DDD Model 972.
Recall # Z-0876-03;
c) Pulsar Multiprogrammable Pacemaker, DDD Model 976.
Recall # Z-0877-03;
d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270.
Recall # Z-0878-03;
e) Pulsar Multiprogrammable Pacemaker, DDDDR Model 1272.
Recall # Z-0879-03;
f) Pulsar Max Multiprogrammable Pacemaker.
Recall # Z-0880-03;
g) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1284. Recall # Z-0881-03;
h) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1286. Recall # Z-0882-03;
i) Discovery Multiprogrammable Pacemaker, DDDR
Model 1273. Recall # Z-0883-03;
j) Discovery Multiprogrammable Pacemaker, DDDR Model
1274. Recall # Z-0884-03;
k) Discovery II Multiprogrammable Pacemaker, DDD Model
981. Recall # Z-0885-03;
l) Discovery II Multiprogrammable Pacemaker, DDDR Model
1280. Recall # Z-0886-03;
m) Discovery II Multiprogrammable Pacemaker, DDDR Model
1283. Recall # Z-0887-03;
n) Meridian Multiprogrammable Pacemaker, DDDR Model
1275. Recall # Z-0888-03;
o) Meridian Multiprogrammable Pacemaker, DDDR Model
1286. Recall # Z-0889-03;
p) Insignia Plus Multiprogrammable Pacemaker, DDD Model
985. Recall # Z-0890-03;
q) Insignia Plus Multiprogrammable Pacemaker, DDD Model
986. Recall # Z-0891-03;
r) Insignia Plus Multiprogrammable Pacemaker, DDDR Model
1294. Recall # Z-0892-03;
s) Insignia Plus Multiprogrammable Pacemaker, DDDR Model
1295. Recall # Z-0893-03;
t) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1296. Recall # Z-0894-03;
u) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1297. Recall # Z-0895-03;
v) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1298. Recall # Z-0896-03;
w) Contak TR Multiprogrammable Pacemaker, DDDR Model
1241. Recall # Z-0897-03;
REASON
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Guidant Corp-Cpi Division, St Paul, MN, by letter dated May 6, 2003. Firm initiated field correction is ongoing. A May 6, 2003 letter to physicians gave recommendations for avoiding the problem and indicated that software to prevent the problem would be introduced.
VOLUME OF PRODUCT IN COMMERCE
298,000.
DISTRIBUTION
Nationwide, and Internationally.
