Delphi Medical Systems Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
Brand
Delphi Medical Systems
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Delphi Medical Systems is recalling Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 1286405 due to Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
Recommended Action
Per FDA guidance
Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.
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 noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026