Class I Medical Device Recalls - Medtronic 8870 Software Application Card Version AAA 02

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

Medical Device Recalls
Class I Recall: Medtronic 8870 Software Application Card Version AAA 02

Date Recall Initiated	August 24, 2004
Product:	8870 software application card version AAA 02, which is used in conjunction with the Model 8840 N’Vision Clinician Programmer
Use:	The software application card is the software that is used with the Medtronic N’Vision Clinician Programmer to control the administration of medication of the Synchromed and Synchromed EL implantable infusion pumps.
Recalling Firm:	Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, Minnesota 55432
Reason for Recall:	Several pump infusion modes require the entry of a time duration or interval. Medtronic has received reports of the entry of hours into the minutes field, which has resulted in deaths and injuries due to drug overdose.
Public Contact:	Questions about this recall should be directed to Medtronic at 800-328-0810, extension 88608.
FDA District:	Minneapolis
FDA Comment:	Customers should follow instructions sent to them by Medtronic, Inc. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
	For additional information on this product recall, see the Medtronic Press Release. Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00867.html. Scroll down to "Recalls and Field Corrections: Devices - Class I".

Updated October 19, 2004

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH