Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432
FDA device recall Z-0744-2008 · posted 2008-02-02 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Pump motor stall due to gear shaft wear
- Action taken
- Beginning August 3, 2007, consignees were notified by letter. The letter "Medtronic Urgent: Medical Device Correction Aug 2007" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 23, 895 total for recalls Z-0739-0746-2008
- Distribution
- Worldwide: USA including 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, PR, RI, S
- Date initiated
- 2007-08-03
- Date posted
- 2008-02-02
- Date terminated
- 2011-06-06
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.