Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432
FDA device recall Z-0952-2008 · posted 2008-02-09 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Pump Motor Stall; pumps can stall due to gear shaft wear.
- Action taken
- Begining 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
- 81,023 total for recalls Z-0950-0957-2008
- 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, SC
- Date initiated
- 2007-08-03
- Date posted
- 2008-02-09
- Date terminated
- 2011-12-27
- Location
- Minneapolis, MN
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