Pulse-generator, Pacemaker, External

Single Chamber Temporary External Pacemaker, Model 53401

A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).

Medtronic Dual Chamber Temporary External Pacemaker, Model 5392.

Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.

Oscor PACE 203H, Dual-Chamber External Pulse Generator

The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a certain manufacturing period malfunction (i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t

St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator

The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a certain manufacturing period malfunction (i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t

ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.