Z-1445-06

Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL...

Name: Z-1445-06 Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL...
Creator: Delphi Medical Systems
Published: 2006-03-29
License: https://open.fda.gov/license/

Delphi Medical Systems / initiated 2006-03-29 / Terminated

FDA source

Delphi Medical Systems began a recall of Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8 on 2006-03-29. The reason FDA records is "Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1445-06
Status: Terminated
Initiated: 2006-03-29
Posted: 2006-08-26
Terminated: 2006-10-16
Recalling firm: Delphi Medical Systems
Product: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
Product code: FRN Pump, Infusion
Reason for recall: Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
FDA root cause: Other
Action: Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.
Quantity in commerce: 22 US and 147 international.
Distribution: Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.
Product codes and lots: All serial numbers.

Product code FRN

K953896Class IIThe Imed Ambulatory Infusion Pump, Administration SetsImed Corp. / cleared 1996-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)