Recall Z-1668-2013 ยท FPA Set, Administration, Intravascular
Medtronic MiniMed
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
| Date | Jul 9, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin. |
| Root cause | Device Design |
| Action | Medtronic, Inc. sent an Urgent Medical Device Safety Notification letter dated June 10, 2013, to all affected consignees. The letter identified the product and notified healthcare professionals of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. The letter informed the consignees that it applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps. Paradigm Insulin Pump users, distributors, and healthcare professionals were all instructed to contact Medtronic's |
| Quantity | 11,000,000 units |
| Distribution | Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Fre |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011071 | PARADIGM QUICK-SET INFUSION SET Maersk Medical A/S, Jun 7, 2001 |