Medtronic MiniMed, Inc.: MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Is my product affected?

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

• UPC 00763000404550
• UPC 00763000404567

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

What happened

Medtronic MiniMed has recalled 16 loaner MiniMed 640G insulin pumps distributed internationally to Germany, Denmark, Austria, the Netherlands, the United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, and Northern Ireland. The pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad and allow moisture to enter the device.

This damage could result in insulin over- or under-delivery, potentially causing low blood sugar, high blood sugar, or diabetic ketoacidosis. The affected pumps are model MMT-1711 or MMT-1712 with specific serial numbers listed in the recall notice. The source does not specify a remedy or action for affected consumers.

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

Hazard

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Details from the source

Reason for recall: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Distribution: International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland. Quantity: 16 Lot/code info: Model/UDI-DI/Serial Numbers: MMT-1711/00763000404550/NG2660048H, NG2663343H, NG3015306H; MMT-1712/00763000404567/NG2628486H, NG2758213H, NG2999651H, NG3349198H, NG3351719H, NG2678842H, NG2831821H, NG2831546H, NG2932027H, NG3049657H, NG3033094H, NG2831538H, NG3738739H

Source

Official record: FDA (Device enforcement) ↗

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

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