Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Osypka Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56121
  • Event Risk Class
    Class 2
  • Event Number
    Z-2444-2010
  • Event Initiated Date
    2010-06-30
  • Event Date Posted
    2010-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93070
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    pulse-generator, pacemaker, external - Product Code DTE
  • 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.
  • 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

Device

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
  • Model / Serial
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of CA & FL
  • Product Description
    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.
  • Manufacturer
    Osypka Medical Inc

Manufacturer

Osypka Medical Inc
  • Manufacturer Address
    Osypka Medical Inc, 7855 Ivanhoe Ave Ste 226, La Jolla CA 92037-4561
  • Manufacturer Parent Company (2017)
    Osypka Medical Inc
  • Source
    USFDA