Home › Device types › DTE
Pulse-Generator, Pacemaker, External
FDA product code DTE · Class 2 · Cardiovascular
26
Registered devices
13,014
Adverse events
5
Recalls
65
510(k) clearances
Devices with this code
CARDIOTRONIC — Osypka Medical GmbHPK-67-S/0,8m — BIOTRONIK SE & Co. KGPK-83-B/1,5m — BIOTRONIK SE & Co. KGNA — MEDTRONIC, INC.Solo Pace Control System — SOLO PACE INC.CARDIOTRONIC — Osypka Medical GmbHSoloPace EPG — SOLO PACE INC.PACE 203H — Oscor Inc.CARDIOTRONIC — Osypka Medical GmbHNA — MEDTRONIC, INC.PK-175/2,3m — BIOTRONIK SE & Co. KGNA — MEDTRONIC, INC.PACE 203H — Oscor Inc.Solo Pace Control System — SOLO PACE INC.NA — MEDTRONIC, INC.CARDIOTRONIC — Osypka Medical GmbHPACE 101H — Oscor Inc.PK-83-B/2,5m — BIOTRONIK SE & Co. KGNA — MEDTRONIC, INC.5391 — Oscor Inc.NA — MEDTRONIC, INC.Osypka Medical — Osypka Medical GmbHPRO PADZ — Zoll Medical CorporationPRO PADZ — Zoll Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-28 | Bio-Detek, Inc. | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. |
| 2018-06-06 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a pati |
| 2015-03-17 | Medtronic Inc. Cardiac Rhythm Disease Management | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain |
| 2010-06-30 | Osypka Medical Inc | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with som |
| 2010-06-30 | Osypka Medical Inc | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with som |
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