FDA Medical Device Recalls (openFDA)
Medtronic Gastroenterology / Urology: Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
- Recall number
- Z-0830-06
- Recalling firm
- Medtronic Gastroenterology / Urology
- Product
- Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
- Status
- Terminated
- Initiated
- 2006-01-25
- Posted
- 2006-05-03
- Terminated
- 2006-12-21
- Reason
- Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
- Root cause
- Other
- Action
- An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.
- Quantity
- 25 individual catheters
- Distribution
- within US only: MI, PA, TX
- Lot, serial or model codes
- Lot 0001491
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FFT
- 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