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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0029-2018 - Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or C...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0030-2018 - Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224
Implantation of a singl...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0031-2018 - Assurity MRI Model Numbers: PM1272, PM2272
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: ...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0032-2018 - Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate progr...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0038-2018 - 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...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0034-2018 - PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, tha...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0035-2018 - PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply a...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0036-2018 - PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power ...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0037-2018 - PM 1260 ASSURITY +
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 p...
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2
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06/12/2018
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St Jude Medical Inc.
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Z-0033-2018 - Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.
The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care S...
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2
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06/12/2018
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St Jude Medical Inc.
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