Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtroni
FDA device recall Z-0517-2008 · posted 2008-05-07 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FFT
- Quantity affected
- 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,
- Date initiated
- 2007-12-03
- Date posted
- 2008-05-07
- Date terminated
- 2012-05-03
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |