Company:St Jude Medical
Date of Enforcement Report:12/27/2006
Class:ll
PRODUCT
a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007;
b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3650, Recall # Z- 0297-2007;
c) St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR
Model 5376; Pulse Generators (pacemakers), Recall # Z-0298-2007
REASON
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.
CODE
All Devices (all serial numbers for the devices referenced in the advisory.)
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter on October 12, 2006, and by press release on October 13, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
229,411 devices
DISTRIBUTION
Nationwide and Internationally
