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Terminated

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

FDA Recall Z-0517-2008 · Posted 2008-05-07

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeFFT
Date Initiated2007-12-03
Date Terminated2012-05-03
Product Quantity169,365 individual Bravo capsule and delivery systems have been sold worldwide

Reason for Recall

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

Firm 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.

Root Cause

Labeling Change Control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc. · 2000-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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