Home › Device types › OSR
Pacemaker/Icd/Crt Non-Implanted Components
FDA product code OSR · Class 3 · Unknown
245
Registered devices
55,908
Adverse events
15
Recalls
0
510(k) clearances
Devices with this code
LATITUDE™ Programming System — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.PSW — BIOTRONIK SE & Co. KGMyCareLink™ — MEDTRONIC, INC.MyCareLink™ — MEDTRONIC, INC.LATITUDE Consult™ — BOSTON SCIENTIFIC CORPORATIONLATITUDE® NXT — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.MyCareLink™ — MEDTRONIC, INC.PSW — BIOTRONIK SE & Co. KGPSW — BIOTRONIK SE & Co. KGEntrant™ — ST. JUDE MEDICAL, INC.SW HMSC 3.64 — BIOTRONIK SE & Co. KGCARELINK® MONITOR — MEDTRONIC, INC.Home Monitoring Service Center — BIOTRONIK SE & Co. KGHome Monitoring Service Center — BIOTRONIK SE & Co. KGLATITUDE® NXT — BOSTON SCIENTIFIC CORPORATIONHome Monitoring Service Center — BIOTRONIK SE & Co. KGLATITUDE® Communicator — BOSTON SCIENTIFIC CORPORATIONMyCareLink™ — MEDTRONIC, INC.myMerlinPulse™ — ST. JUDE MEDICAL, INC.NA — BOSTON SCIENTIFIC CORPORATIONGallant™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-10 | St. Jude Medical, Cardiac Rhythm Management Division | Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and c |
| 2021-10-12 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The processing of collected episode data may fail due to a software error. |
| 2021-04-06 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time b |
| 2020-01-30 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitiv |
| 2020-01-30 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitiv |
| 2019-10-03 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of |
| 2019-10-03 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of |
| 2019-10-03 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of |
| 2019-01-17 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable |
| 2019-01-17 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reachi |
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