Medtronic MiniMed Paradigm Model 511 and 512 Insulin Infusion Pumps Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Paradigm Model 511 and 512 Insulin Infusion Pumps
Brand
Medtronic MiniMed
Lot Codes / Batch Numbers
Codes are irrelevant
Products Sold
Codes are irrelevant
Medtronic MiniMed is recalling Paradigm Model 511 and 512 Insulin Infusion Pumps due to Water ingresses into the device when in prolonged contact with water causing device to malfunction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
Recommended Action
Per FDA guidance
The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026