Recall Z-0038-2018— St Jude Medical Inc.
Class II · Terminated
Class II FDA medical device recall by St Jude Medical Inc., initiated 2017-08-28, terminated 2020-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications..
- Recalling firm
- St Jude Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-28
- Terminated
- 2020-07-08
- Firm location
- Sylmar, CA, United States
Product description
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
Reason for recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.