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

FDA device recall Z-1334-04 · posted 2004-09-23 · Terminated

Recall details

Recalling firm

Medtronic Inc, Neurological & Spinal Division

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LKK

Quantity affected

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.

Date initiated

2004-08-24

Date posted

2004-09-23

Date terminated

2005-12-13

Location

Columbia Heights, MN