Recall Z-0517-2008
Medtronic Neuromodulation · initiated December 3, 2007
Product
Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432
Codes / 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.
Reason for recall
Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0517-2008
- Initiated
- December 3, 2007
- Posted by FDA
- May 7, 2008
- Terminated
- May 3, 2012
- Product code
- FFT – Electrode, Ph, Stomach
- Quantity
- 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…
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN