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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.
Brand
Medtronic Gastroenterology Urology
Lot Codes / Batch Numbers
Lots 0001391 and 0001464
Products Sold
Lots 0001391 and 0001464
Medtronic Gastroenterology Urology is recalling Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distrib due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, NY, NC
Page updated: Jan 10, 2026