Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H 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NG1419504H NG1419525H NG1419497H NG1419521H NG1419342H NG1419381H NG1419470H NG1419486H NG1419335H NG1419492H NG1419462H NG1419454H NG1419478H NG1419397H NG1419522H NG1419275H NG1419483H NG1419322H NG1419395H NG1419475H NG1419385H NG1419469H NG1419337H NG1419452H NG1419005H NG1419390H NG1419039H NG1419015H NG1418978H NG1419008H NG1419300H NG1419000H NG1419340H NG1419296H NG1419532H NG1419459H NG1419393H NG1419378H NG1419333H NG1419555H NG1419518H NG1419304H NG1419388H NG1419317H NG1419494H NG1419383H NG1419315H NG1419488H NG1419292H NG1419520H NG1419365H NG1419330H NG1418585H NG1417973H NG1418611H NG1418613H NG1418540H NG1418492H NG1418576H NG1418542H NG1418487H NG1418616H NG1418612H NG1418614H NG1417881H NG1418662H NG1418563H NG1417887H NG1418594H NG1418539H NG1418593H NG1418436H NG1418514H NG1418456H NG1418603H NG1418490H NG1418421H NG1418565H NG1417987H NG1417902H NG1419361H NG1419530H NG1419312H NG1419463H NG1419369H NG1419472H NG1419524H NG1419392H NG1419480H NG1419293H NG1419456H 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NG1418671H NG1418718H NG1418714H NG1418683H NG1418729H NG1418693H NG1418655H NG1417615H NG1418621H NG1418650H NG1418682H NG1418571H NG1418710H NG1418623H NG1417653H NG1418733H NG1418590H NG1418681H NG1418607H NG1418644H NG1418673H NG1418738H NG1418724H NG1418700H NG1418649H NG1418648H NG1418705H NG1418717H NG1418667H NG1418728H NG1418740H NG1418695H NG1418764H NG1418598H NG1418587H NG1418685H NG1418392H NG1418668H NG1418581H NG1418550H NG1417970H NG1418956H NG1418987H NG1418882H NG1418941H NG1419037H NG1419002H NG1419004H NG1419014H NG1419007H NG1418842H NG1418961H NG1418970H NG1418996H NG1418871H NG1418963H NG1418959H NG1418731H NG1418643H NG1418702H NG1418739H NG1418730H NG1418751H NG1418792H NG1418723H NG1418836H NG1418646H NG1418754H NG1418746H NG1418704H NG1418810H NG1418654H NG1418742H NG1418815H NG1418755H NG1418817H NG1418807H NG1418801H NG1418849H NG1418781H NG1418692H NG1418859H NG1418854H NG1417181H NG1417259H NG1417187H NG1417019H NG1417206H NG1417178H NG1417385H NG1417090H NG1417183H NG1417144H NG1417340H NG1417099H NG1417160H NG1417261H NG1417102H NG1417051H NG1417023H NG1417082H NG1417028H NG1417072H NG1417080H NG1417126H NG1417134H NG1417083H NG1417085H NG1417293H NG1417318H NG1417251H NG1417122H NG1417013H NG1417157H NG1417152H NG1417279H NG1417263H NG1417095H NG1417253H NG1417120H NG1417014H NG1417256H NG1417166H NG1417069H NG1417215H NG1417249H NG1417351H NG1417176H NG1417252H NG1417250H NG1417020H NG1417258H NG1417372H NG1417081H NG1419024H NG1418995H NG1419025H NG1419006H NG1419013H NG1419319H NG1418977H NG1418999H NG1419028H NG1419303H NG1419294H NG1419324H NG1419298H NG1419001H NG1419027H NG1419026H NG1419036H NG1419310H NG1419019H NG1418993H NG1419011H NG1419034H NG1418992H NG1419380H NG1419291H NG1418997H NG1417112H NG1417223H NG1417093H NG1417107H NG1417055H NG1417086H NG1417189H NG1417117H NG1417031H NG1417084H NG1417275H NG1417137H NG1417094H NG1417173H NG1417361H NG1417053H NG1417061H NG1417196H NG1417077H NG1417026H NG1417148H NG1417101H 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc.
- Reason for Recall:
- Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Product Codes/Lot Numbers:
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H NG1399210H NG1399441H NG1399997H 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NG1410857H NG1410919H NG1410668H NG1410769H NG1410472H NG1410529H NG1410677H NG1410503H NG1410392H NG1410624H NG1410455H NG1410424H NG1410129H NG1410476H NG1410402H NG1410404H NG1410500H NG1410441H NG1410501H NG1410515H NG1410510H NG1410454H NG1410370H NG1410467H NG1410612H NG1410520H NG1410512H NG1410674H NG1410171H NG1410720H NG1410727H NG1410172H NG1410666H NG1410526H NG1410610H NG1410611H NG1410524H NG1410433H NG1410767H NG1410972H NG1410735H NG1410763H NG1410613H NG1410971H NG1410773H NG1410699H NG1410913H NG1410672H NG1410509H NG1410772H NG1410609H NG1410939H NG1409986H NG1410225H NG1410125H NG1410211H NG1410416H NG1410363H NG1410341H NG1410373H NG1410180H NG1410231H NG1410230H NG1410220H NG1410223H NG1410152H NG1410174H NG1410155H NG1410145H NG1410157H NG1410367H NG1410188H NG1409896H NG1410169H NG1410226H NG1409985H NG1410227H NG1410170H NG1410095H NG1409969H NG1410139H NG1410412H NG1410408H NG1410505H NG1410511H NG1410142H NG1410224H NG1410438H NG1410447H NG1410418H NG1410192H NG1410173H NG1410459H NG1409992H NG1410410H NG1410451H NG1410232H NG1410365H NG1410013H NG1410108H NG1409970H NG1410468H NG1409901H NG1410422H NG1410121H NG1410221H NG1410203H NG1410213H NG1410426H NG1410471H NG1404575H NG1405040H NG1404891H NG1404798H NG1404541H NG1405533H NG1404566H NG1405505H NG1404898H NG1404559H NG1404524H NG1404882H NG1405555H NG1404893H NG1404499H NG1404793H NG1404540H NG1405528H NG1395006H NG1404607H NG1405540H NG1404945H NG1405187H NG1404605H NG1404539H NG1394968H NG1404828H NG1404504H NG1404549H NG1404946H NG1404861H NG1405606H NG1405530H NG1404779H NG1404850H NG1404640H NG1404527H NG1404634H NG1405599H NG1405539H NG1404519H NG1404952H NG1404857H NG1404790H NG1417412H NG1417543H NG1417534H NG1417709H NG1417802H NG1417651H NG1417364H NG1417388H NG1417863H NG1417474H NG1417606H NG1417163H NG1417923H NG1417817H NG1417649H NG1417673H NG1417509H NG1417376H NG1417338H NG1417663H NG1417346H NG1417257H NG1417383H NG1417549H NG1417265H NG1417324H NG1417483H NG1417489H NG1418554H NG1417397H NG1418390H NG1418406H NG1418434H NG1418473H NG1418474H NG1418429H NG1417824H NG1418409H NG1418411H NG1418423H NG1417834H NG1418415H NG1417943H NG1418384H NG1418424H NG1418438H NG1418427H NG1417967H NG1418426H NG1418449H NG1417796H NG1418416H NG1418447H NG1417393H NG1417377H NG1417296H NG1417580H NG1417097H NG1417365H NG1417330H NG1417287H NG1417348H NG1417098H NG1417208H NG1417194H NG1417371H NG1417379H NG1417947H NG1417607H NG1417366H NG1417459H NG1417675H NG1417476H NG1417527H NG1417321H NG1417143H NG1417515H NG1417327H NG1417415H NG1417741H NG1417710H NG1417451H NG1417277H NG1417370H NG1417609H NG1417109H NG1417501H NG1417538H NG1417017H NG1417394H NG1417661H NG1417708H NG1417358H NG1417689H NG1417400H NG1417091H NG1417486H NG1417792H NG1417386H NG1417559H NG1417507H NG1418782H NG1418788H NG1418818H NG1418853H NG1418766H NG1418784H NG1418803H NG1418771H NG1418768H NG1417021H NG1417268H NG1419500H NG1419375H NG1419535H NG1419551H NG1419504H NG1419525H NG1419497H NG1419521H NG1419342H NG1419381H NG1419470H NG1419486H NG1419335H NG1419492H NG1419462H NG1419454H NG1419478H NG1419397H NG1419522H NG1419275H NG1419483H NG1419322H NG1419395H NG1419475H NG1419385H NG1419469H NG1419337H NG1419452H NG1419005H NG1419390H NG1419039H NG1419015H NG1418978H NG1419008H NG1419300H NG1419000H NG1419340H NG1419296H NG1419532H NG1419459H NG1419393H NG1419378H NG1419333H NG1419555H NG1419518H NG1419304H NG1419388H NG1419317H NG1419494H NG1419383H NG1419315H NG1419488H NG1419292H NG1419520H NG1419365H NG1419330H NG1418585H NG1417973H NG1418611H NG1418613H NG1418540H NG1418492H NG1418576H NG1418542H NG1418487H NG1418616H NG1418612H NG1418614H NG1417881H NG1418662H NG1418563H NG1417887H NG1418594H NG1418539H NG1418593H NG1418436H NG1418514H NG1418456H NG1418603H NG1418490H NG1418421H NG1418565H NG1417987H NG1417902H NG1419361H NG1419530H NG1419312H NG1419463H NG1419369H NG1419472H NG1419524H NG1419392H NG1419480H NG1419293H NG1419456H NG1419376H NG1417314H NG1418405H 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NG1417099H NG1417160H NG1417261H NG1417102H NG1417051H NG1417023H NG1417082H NG1417028H NG1417072H NG1417080H NG1417126H NG1417134H NG1417083H NG1417085H NG1417293H NG1417318H NG1417251H NG1417122H NG1417013H NG1417157H NG1417152H NG1417279H NG1417263H NG1417095H NG1417253H NG1417120H NG1417014H NG1417256H NG1417166H NG1417069H NG1417215H NG1417249H NG1417351H NG1417176H NG1417252H NG1417250H NG1417020H NG1417258H NG1417372H NG1417081H NG1419024H NG1418995H NG1419025H NG1419006H NG1419013H NG1419319H NG1418977H NG1418999H NG1419028H NG1419303H NG1419294H NG1419324H NG1419298H NG1419001H NG1419027H NG1419026H NG1419036H NG1419310H NG1419019H NG1418993H NG1419011H NG1419034H NG1418992H NG1419380H NG1419291H NG1418997H NG1417112H NG1417223H NG1417093H NG1417107H NG1417055H NG1417086H NG1417189H NG1417117H NG1417031H NG1417084H NG1417275H NG1417137H NG1417094H NG1417173H NG1417361H NG1417053H NG1417061H NG1417196H NG1417077H NG1417026H NG1417148H NG1417101H NG1419012H NG1418981H NG1419010H NG1417272H NG1418985H NG1418967H NG1418958H NG1418911H NG1418905H NG1418876H NG1418910H NG1418972H NG1418886H NG1418950H NG1418943H NG1418806H NG1418884H NG1418902H NG1418868H NG1418747H NG1418971H NG1418825H NG1418899H NG1418866H NG1418931H NG1418896H NG1418952H NG1418945H NG1418809H NG1418895H NG1418482H NG1418575H NG1418491H NG1418513H NG1418562H NG1417827H NG1418526H NG1418024H NG1418455H NG1418547H NG1418552H NG1418519H NG1418584H NG1418499H NG1418566H NG1417931H NG1418556H NG1418543H NG1418478H NG1418582H NG1418908H NG1418840H NG1418973H NG1418915H NG1418732H NG1418880H NG1418833H NG1418893H NG1418820H NG1418897H NG1418925H NG1418889H NG1418759H NG1418795H NG1418922H NG1418929H NG1418948H NG1418924H NG1418672H NG1418821H NG1418870H NG1418873H NG1418861H NG1418765H NG1417169H NG1417290H NG1417221H NG1417149H NG1418907H NG1418845H NG1418680H NG1418955H NG1418735H NG1418913H NG1418775H NG1418869H NG1418903H NG1418860H NG1418975H NG1418699H NG1418793H NG1418920H NG1418826H NG1418633H NG1418679H NG1418919H NG1418639H NG1418791H NG1418891H NG1418851H NG1418760H NG1418875H NG1418877H NG1418690H NG1418694H NG1418885H NG1427977H NG1427990H NG1427979H NG1427999H NG1428011H NG1427987H NG1427988H NG1428043H NG1404988H NG1428004H NG1427978H NG1427986H NG1428019H NG1428016H NG1428017H NG1428018H NG1428020H NG1427995H NG1428002H NG1427982H NG1427983H NG1427994H NG1428012H NG1428015H NG1428003H NG1428351H NG1428347H NG1428237H NG1428261H NG1428405H NG1428359H NG1428179H NG1428401H NG1428311H NG1428084H NG1428259H NG1428340H NG1428367H NG1428206H NG1428372H NG1428150H NG1428409H NG1428403H NG1428374H NG1428371H NG1428381H NG1428336H NG1428087H NG1428074H NG1428117H NG1428407H NG1428376H NG1428363H NG1428404H NG1428149H NG1428055H NG1428047H NG1428125H NG1428050H NG1428112H NG1428057H NG1428062H NG1428120H NG1428217H NG1428052H NG1428121H NG14
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0683-2019
Related Recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.