Home › Device types › NVZ
Pulse Generator, Permanent, Implantable
FDA product code NVZ · Class 3 · Unknown
341
Registered devices
96,105
Adverse events
40
Recalls
0
510(k) clearances
Devices with this code
Edora 8 SR-T — BIOTRONIK SE & Co. KGReply — MICROPORT CRM SRLAdapta™ — MEDTRONIC, INC.SJM™ — ST. JUDE MEDICAL, INC.Ellipse™ — ST. JUDE MEDICAL, INC.MEDTRONIC CARELINK EXPRESS™ — MEDTRONIC, INC.Adapta™ — MEDTRONIC, INC.Sustain™ — ST. JUDE MEDICAL, INC.Esprit — MICROPORT CRM SRLLocator™ — ST. JUDE MEDICAL, INC.CARELINK® MONITOR — MEDTRONIC, INC.Current Accel™ — ST. JUDE MEDICAL, INC.Evera MRI™ S DR SureScan® — MEDTRONIC, INC.Adapta™ — MEDTRONIC, INC.MyCareLink™ — MEDTRONIC, INC.Visia AF MRI™ VR SureScan™ — MEDTRONIC, INC.Crome™ VR MRI SureScan™ — MEDTRONIC, INC.FORTIFY™ — ST. JUDE MEDICAL, INC.Endurity™ — ST. JUDE MEDICAL, INC.Current® — ST. JUDE MEDICAL, INC.Locator™ — ST. JUDE MEDICAL, INC.Sensia™ — MEDTRONIC, INC.MyCareLink™ — MEDTRONIC, INC.Evera™ XT DR — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-18 | Medtronic, Inc. | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for t |
| 2025-06-18 | Medtronic, Inc. | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for t |
| 2025-04-29 | Medtronic, Inc. | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms |
| 2024-10-01 | Abbott Medical | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the- |
| 2024-10-01 | Abbott Medical | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the- |
| 2024-07-11 | Medtronic Inc. | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability |
| 2021-11-08 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a c |
| 2021-03-15 | St. Jude Medical, Cardian Rhythm Management Division | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected dev |
| 2021-03-15 | St. Jude Medical, Cardian Rhythm Management Division | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected dev |
| 2020-06-04 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some |
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