Home › Device types › KRG
Programmer, Pacemaker
FDA product code KRG · Class 3 · Cardiovascular
91
Registered devices
24,159
Adverse events
11
Recalls
25
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.Viva™ XT CRT-D — MEDTRONIC, INC.PK Electrode Clip — BIOTRONIK SE & Co. KGViva™ Quad XT CRT-D — MEDTRONIC, INC.Viva™ Quad S CRT-D — MEDTRONIC, INC.Viva™ XT CRT-D — MEDTRONIC, INC.Viva™ XT CRT-D — MEDTRONIC, INC.Medtronic CareLink® Programmer — MEDTRONIC, INC.Medtronic CareLink® Programmer — MEDTRONIC, INC.NA — BOSTON SCIENTIFIC CORPORATIONViva™ Quad XT CRT-D — MEDTRONIC, INC.Viva™ S CRT-D — MEDTRONIC, INC.Viva™ S CRT-D — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Medtronic CareLink® Programmer — MEDTRONIC, INC.NA — MEDTRONIC, INC.Identity® — ST. JUDE MEDICAL, INC.Renamic — BIOTRONIK SE & Co. KGViva™ S CRT-D — MEDTRONIC, INC.Protecta™ CRT-D — MEDTRONIC, INC.Viva™ Quad S CRT-D — MEDTRONIC, INC.Viva™ S CRT-D — MEDTRONIC, INC.Viva™ Quad S CRT-D — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-17 | Medtronic, Inc. | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous ele |
| 2025-06-17 | Medtronic, Inc. | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous ele |
| 2016-09-29 | Sorin Group USA, Inc. | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may |
| 2016-09-29 | Sorin Group USA, Inc. | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may |
| 2010-07-22 | Boston Scientific CRM Corp | Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain B |
| 2010-03-15 | Boston Scientific CRM Corp | Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrilla |
| 2006-10-06 | St Jude Medical CRMD | 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 |
| 2006-10-06 | St Jude Medical CRMD | 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 |
| 2006-06-24 | Boston Scientific CRM Corp | Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion in |
| 2005-06-17 | Guidant Corporation | Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resul |
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