Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of th

FDA device recall Z-1415-06 · posted 2006-09-09 · Terminated

Recall details

Recalling firm

Medtronic Neurological

Reason for recall

Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.

Action taken

An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.

Root cause

Other

Status

Terminated

Product code

LKK

Quantity affected

Recalls Z-1414-1415-06-USA- 359 devices. - Foreign 575 devices

Distribution

Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia

Date initiated

2006-07-21

Date posted

2006-09-09

Date terminated

2007-06-21

Location

Minneapolis, MN