FDA Medical Device Recalls (openFDA)
Medtronic Gastroenterology / Urology: Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.
- Recall number
- Z-1159-06
- Recalling firm
- Medtronic Gastroenterology / Urology
- Product
- Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.
- Status
- Terminated
- Initiated
- 2006-04-06
- Posted
- 2006-06-22
- Terminated
- 2007-01-16
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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
- Lot, serial or model codes
- Lots 0001391 and 0001464
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KLA
- Firm FEI
- 1000135098
- Firm city
- Shoreview
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28