Z-1334-04

8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with...

Name: Z-1334-04 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with...
Creator: Medtronic Inc, Neurological & Spinal Division
Published: 2004-08-24
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2004-08-24 / Terminated / root cause: software

FDA source

Medtronic Inc, Neurological & Spinal Division began a recall of 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer on 2004-08-24. The reason FDA records is "With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1334-04
Status: Terminated
Initiated: 2004-08-24
Posted: 2004-09-23
Terminated: 2005-12-13
Recalling firm: Medtronic Neuromodulation
Product: 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.
Root cause tag: software
FDA root cause: Other
Action: Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.
Quantity in commerce: 3,218 cards distributed in US, plus 1,248 distributed outside of the US
Distribution: These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.
Product codes and lots: Software Version AAA 02, BBB 04, BBC 02, and BBD 01

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)