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Terminated

Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 20 ml Pumps Model 8637-20 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

FDA Recall Z-2181-2008 · Posted 2008-09-03

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2008-05-01
Date Terminated2011-12-11
Product Quantity7468

Reason for Recall

SynchroMed II pumps (non-implanted) may have been manufactured without propellant.

Firm Action

Consignees were contacted by "Medtronic Urgent: Medical Device Recall" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Product and Accounting for Lost Inventory Product. Contact Medtronic at 1-800-707-0933.

Root Cause

Process control

Distribution Pattern

AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, WY, Australia, Canada ,Austria, Belgium, Cyprus, Russian Federation, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Ireland, Italy, Kuwait, Luxembourg, Netherlands, Norway, Poland, Portugal, Reunion, San Marino, Slovenia, South Africa, Spain, Sweden Switzerland, Turkey, United Arab Emirates, United Kingdom, Vatican City, Saudi Arabia, Hong Kong, Latin America, Brazil, Puerto Rico, and Dominican Republic.

Official Source

View FDA Recall →

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

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