St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator

FDA device recall Z-2444-2010 · posted 2010-09-21 · Terminated

Recall details

Recalling firm

Osypka Medical Inc

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

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

DTE

Quantity affected

12 units (US Only)

Distribution

Nationwide Distribution: USA including states of CA & FL

Date initiated

2010-06-30

Date posted

2010-09-21

Date terminated

2012-08-10

Location

La Jolla, CA

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