—#66713

Product

Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432

FDA product code: FFT — Electrode, Ph, Stomach
Device class: Class 1
Medical specialty: Gastroenterology, Urology
510(k) numbers: K002028
Affected lot / code info: 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.

Why it was recalled

Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-12-03
Posted by FDA: 2008-05-07
Terminated: 2012-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66713. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.