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FDA (Device enforcement)Recalled 2022-05-23class ii

Medtronic MiniMed: MiniMed 630G Insulin Pump (U.S. and Canada Version)

Is my product affected?

MiniMed 630G Insulin Pump (U.S. and Canada Version)

  • UPC 643169656840
  • UPC 763000090197
  • UPC 763000190439
  • UPC 763000316631
  • UPC 763000072520
  • UPC 763000166519
  • UPC 763000256807
  • UPC 763000316655
  • UPC 763000367053
  • UPC 643169752726
  • UPC 763000101527
  • UPC 763000157043
  • UPC 763000190446
  • UPC 763000317591
  • UPC 643169873841
  • UPC 643169878648
  • UPC 763000179632
  • UPC 763000317621
  • UPC 763000367091

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling approximately 126,558 MiniMed 630G insulin pumps distributed in the U.S. and Canada. The pumps are identified by product numbers MMT-1515, MMT-1714, MMT-1715, MMT-1755, and MMT-1754. The recall affects specific serial numbers and UDI-DI codes listed in the recall record, with distribution across all U.S. states and territories.

The recall was issued because the battery cap may deteriorate over time, potentially causing an incomplete battery circuit similar to a detached battery cap. This deterioration could result in loss of power and functionality of the insulin infusion pump. The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.

Details from the source

Reason for recall: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps. Distribution: U.S.: 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, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided Quantity: 126,558 pumps Lot/code info: Product Number/CFN (U.S. and Canada Version) MiniMed 630G (MMT-1515, MMT-1714, MMT-1715, MMT-1755, MMT-1754) UDI-DI Codes: 643169656840 763000090197 763000190439 763000316631 763000072520 763000166519 763000256807 763000316655 763000367053 643169752726 763000101527 763000157043 763000190446 763000317591 643169873841 643169878648 763000179632 763000317621 763000367091 Serial Numbers: U.S. NG1383785H NG2148562H NG1139337H NG1737004H NG1259251H NG1774415H NG1241089H NG1188783H NG1187471H NG1980564H NG1256182H NG2840625H NG2116702H NG2844148H NG2783673H NG1810845H NG2112005H NG2640743H NG2035194H NG2458619H NG2354215H NG2781208H NG2244550H NG1965419H NG2185247H NG2498398H NG1250806H NG1276438H NG2860063H NG2218677H NG2113185H NG2767104H NG2180341H NG1130892H NG2071932H NG2264667H NG1795581H NG2400221H NG2293843H NG2104120H NG2124365H NG2890094H NG2252300H NG1650442H NG1325260H NG1153291H NG2400741H NG2482730H NG2158681H NG1758986H NG2613364H NG1156096H NG1440806H NG2845051H NG1553883H NG1546328H NG1155957H NG1523937H NG2843050H NG1892069H NG2845095H NG2845838H NG2353176H NG2313508H NG2785450H NG1439520H NG2412244H NG1964235H NG1253487H NG2385855H NG2799938H NG2175012H NG2470945H NG2174440H NG2091991H NG1533482H NG1253547H NG2868078H NG2233832H NG2174831H NG1200880H NG1961918H NG2015551H NG2103196H NG2112652H NG2613904H NG2781907H NG2465094H NG2185535H NG2234148H NG2415957H NG2302136H NG2443157H NG1251498H NG2402685H NG1659773H NG2135502H NG2244532H NG3007109H NG2115596H NG1628832

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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