Home › Device types › DXY
Implantable Pacemaker Pulse-Generator
FDA product code DXY · Class 3 · Cardiovascular
59
Registered devices
57,769
Adverse events
75
Recalls
461
510(k) clearances
Devices with this code
Verity™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Victory® — ST. JUDE MEDICAL, INC.Entrant™ — ST. JUDE MEDICAL, INC.BlueSky — MICROPORT CRM SRLBlueSky — MICROPORT CRM SRLMerlin™ — ST. JUDE MEDICAL, INC.Merlin@home™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Identity™ — ST. JUDE MEDICAL, INC.Identity™ — ST. JUDE MEDICAL, INC.Integrity® — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Integrity™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Neutrino™ — ST. JUDE MEDICAL, INC.NA — MEDTRONIC, INC.Merlin.net — ST. JUDE MEDICAL, INC.Identity® — ST. JUDE MEDICAL, INC.SPRINT QUATTRO® — MEDTRONIC, INC.SPRINT QUATTRO® — MEDTRONIC, INC.Verity™ — ST. JUDE MEDICAL, INC.Verity™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-17 | St. Jude Medical, Cardiac Rhythm Management Division | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implant |
| 2022-06-17 | St. Jude Medical, Cardiac Rhythm Management Division | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implant |
| 2022-06-17 | St. Jude Medical, Cardiac Rhythm Management Division | There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery lon |
| 2017-08-28 | St Jude Medical Inc. | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| 2017-08-28 | St Jude Medical Inc. | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| 2017-08-28 | St Jude Medical Inc. | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| 2017-08-28 | St Jude Medical Inc. | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| 2011-09-23 | St Jude Medical CRMD | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but meas |
| 2011-09-23 | St Jude Medical CRMD | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measu |
| 2010-02-11 | Medtronic Inc. Cardiac Rhythm Disease Managment | Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. |
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