Class 2 Device Recall Medtronic MiniMed(TM) Mio(TM)

• Date Initiated by Firm: September 10, 2017
• Create Date: November 18, 2017
• Recall Status: Open, Classified
• Recall Number: Z-0110-2018
• Recall Event ID: 78125
• 510(K)Number: K160648
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
• Code Information: Lot Numbers: 5079672 5079674 5079675 5079697 5079698 5082268 5082622 5082773 5084125 5084460 5084464 5085187 5086974 5087586 5088981 5091305 5095068 5095069 5095177 5095195 5097241 5097967 5098225 5101297 5101624 5103311 5103312 5103409 5103888 5104247 5104632 5106185 5109341 5109702 5109707 5109788 5109789 5109790 5109791 5115440 5115456 5117215 5117935 5119233 5119933 5122173 5122398 5123224 5123228 5123253 5123254 5127870 5127932 5129136 5130064 5130084 5131255 5131853 5131854 5132018 5132951 5133982 5134548 5135127 5135128 5135176 5139007 5140383 5140384 5141588 5143411 5143418 5143983 5143984 5146890 5147485 5148153 5148887 5149493 5150551 5150591 5151310 5151829 5152526 5152962 5153937 5154653 5156088 5156857 5157422 5158190 5158191 5161065 5162223 5162250 5162886 5163245 5163931 5163949 5166387 5167139 5167818 5167819 5169320 5169321 5174510 5176569 5176581 5177287 5178033 5180040 5180041 5068343 5119941 5127869 5127940 5140277 5140347 5150562 5153947 5162256 5165229 5167006 5169334 5175719 5180060 5078337 5079699 5079702 5082269 5082270 5082627 5082774 5082775 5084126 5084127 5084462 5085476 5086923 5087587 5087588 5088385 5088386 5088612 5088613 5088982 5088983 5088984 5088985 5091306 5091307 5095070 5095071 5095072 5095181 5095183 5095196 5095197 5096419 5096420 5096423 5097242 5097968 5098226 5098599 5098828 5099489 5099719 5099720 5100589 5100590 5101625 5101626 5103313 5103314 5103315 5103889 5104633 5104634 5105363 5105364 5105437 5106827 5106828 5107548 5109709 5109711 5109792 5109793 5109794 5109795 5109796 5115441 5115444 5115454 5115455 5117039 5117216 5117267 5117936 5117937 5117938 5117939 5118541 5119234 5119663 5119934 5120632 5120633 5122399 5122400 5122401 5122402 5123226 5123227 5127871 5128409 5128411 5128412 5128413 5128448 5128449 5129142 5130065 5130066 5130067 5131256 5131257 5131855 5131856 5131857 5131858 5132095 5132099 5132952 5132953 5133983 5133984 5134433 5134549 5134550 5135129 5135130 5135131 5136421 5137569 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5129475 5130078 5130079 5130080 5130082 5131265 5131266 5131676 5131677 5131683 5131869 5131870 5131871 5132981 5133986 5133987 5134426 5134552 5134553 5134554 5135143 5135144 5135145 5136425 5136426 5136427 5137567 5137568 5138485 5138486 5138493 5138494 5138495 5139015 5139016 5140276 5140404 5140405 5140406 5140407 5140408 5140409 5140410 5140411 5143134 5143135 5143136 5143417 5143666 5143667 5144001 5144002 5144003 5144004 5144005 5144006 5147495 5148160 5148161 5148162 5149500 5149501 5149502 5150423 5150424 5150439 5150485 5150486 5150487 5150488 5151307 5151308 5151837 5151838 5152338 5152339 5152340 5152346 5152347 5152354 5152355 5152356 5152969 5152970 5152971 5153944 5153945 5153946 5154660 5154661 5155468 5155469 5156453 5156454 5156455 5157366 5157435 5158203 5158204 5158205 5158206 5158207 5158208 5161071 5161072 5161073 5161075 5162210 5162211 5162212 5162213 5162239 5162240 5163252 5163253 5163938 5163939 5163940 5164579 5164580 5164581 5165222 5165223 5165224 5165225 5165226 5165996 5165997 5165998 5165999 5166379 5166380 5167812 5167813 5167814 5167815 5169328 5169329 5169330 5169331 5169332 5169333 5172584 5172585 5172586 5174526 5174527 5174528 5174529 5174530 5175716 5175717 5175718 5176571 5176572 5176573 5176574 5176576 5177294 5177295 5177296 5178030 5178031 5178190 5178191 5178192 5178193 5178194 5178195 5178196 5180058 5180059 5074420 5090839 5106560 5107120 5109821 5119944 5119945 5123252 5130081 5140281 5140354 5144007 5150907 5154663 5162895 5165228 5165983 5167137 5167817
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Medtronic; 888-204-7616
• Manufacturer Reason for Recall: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
• FDA Determined Cause: Component design/selection
• Action: The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
• Quantity in Commerce: 1,513,530 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S