Z-0517-2008

Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and...

Name: Z-0517-2008 Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and...
Creator: Medtronic Neuromodulation
Published: 2007-12-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2007-12-03 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432 on 2007-12-03. The reason FDA records is "Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0517-2008
Status: Terminated
Initiated: 2007-12-03
Posted: 2008-05-07
Terminated: 2012-05-03
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Consignees were notified by an Urgent Device Recall in December 2007. The letter emphasizes to users the current Instructions for Use regarding detachment of the capsule from the deliver system. It advises that users may continue to use the Bravo capsules and delivery systems. It instructs users to discard all copies of the 2005 Bravo pH Monitoring System Interactive Training CD and to use the enclosed 2007 Bravo pH Monitoring System Interactive Training. A "Bravo Delivery System Disassembly Procedure" was also provided with the letter. The letter requests consignees to complete and return the reply form included with the notification. For additional information, contact 1-800-707-0933.
Quantity in commerce: 169,365 individual Bravo capsule and delivery systems have been sold worldwide
Distribution: Worldwide Distribution -- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan , Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Portugal, Russian Federation, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: No devices are being returned. The field action is being done to communicate and emphasize the current Instrucitons for Use (IFU) regarding detachment of the Capsule from the Delivery System.

Product code FFT

K002028Class IBravo Ph Monitoring SystemEndonetics, Inc. / cleared 2000-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)