Recall Z-2444-2010 ยท DTE Pulse-Generator, Pacemaker, External
Osypka Medical Inc
St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purpo
| Date | Sep 21, 2010 (initiated Jun 30, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and |
| Quantity | 12 units (US Only) |
| Distribution | Nationwide Distribution: USA including states of CA & FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE Osypka Medical, Inc., Jun 14, 2002 |