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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator

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  Class 2 Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator see related information
Date Initiated by Firm June 30, 2010
Date Posted September 21, 2010
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-2444-2010
Recall Event ID 56121
510(K)Number K020896  
Product Classification pulse-generator, pacemaker, external - Product Code DTE
Product 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 purposes.
Code Information S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
Recalling Firm/
Manufacturer		 Osypka Medical Inc
7855 Ivanhoe Ave Ste 226
La Jolla CA 92037-4561
For Additional Information Contact
858-454-0021
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 then return the affected devices to Osypka Medical. If you have any questions call (858) 454-0021 or e-mail to mail@osypkamed.com
Quantity in Commerce 12 units (US Only)
Distribution Nationwide Distribution: USA including states of CA & FL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTE and Original Applicant = OSYPKA MEDICAL, INC.
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