Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, In

FDA device recall Z-1159-06 · posted 2006-06-22 · Terminated

Recall details

Recalling firm

Medtronic Gastroenterology / Urology

Reason for recall

Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.

Action taken

Recall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.

Root cause

Other

Status

Terminated

Product code

KLA

Quantity affected

94 catheters (US - 4; OUS - 90)

Distribution

Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain

Date initiated

2006-04-06

Date posted

2006-06-22

Date terminated

2007-01-16

Location

Shoreview, MN