Z-2443-2010

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

Name: Z-2443-2010 Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator /...
Creator: Osypka Medical Inc
Published: 2010-06-30
License: https://open.fda.gov/license/

Osypka Medical GmbH / initiated 2010-06-30 / Terminated / root cause: design

FDA source

Osypka Medical Inc began a recall of Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used... on 2010-06-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2443-2010
Status: Terminated
Initiated: 2010-06-30
Posted: 2010-09-21
Terminated: 2012-08-10
Recalling firm: Osypka Medical GmbH
Product: Oscor PACE 203H, 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.
Product code: DTE Pulse-Generator, Pacemaker, External
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
Root cause tag: design
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 205 units (US Only)
Distribution: Nationwide Distribution: USA including states of CA & FL
Product codes and lots: S/N 0708301 & 1001210 (total = 205)

Product code DTE

K020896Class IIOscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085 Dual-Chamber External Pulse GeneOsypka Medical, Inc. / cleared 2002-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)