FDA Medical Device Recalls (openFDA)
Delphi Medical Systems: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
- Recall number
- Z-1445-06
- Recalling firm
- Delphi Medical Systems
- Product
- Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
- Status
- Terminated
- Initiated
- 2006-03-29
- Posted
- 2006-08-26
- Terminated
- 2006-10-16
- Reason
- Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
- Root cause
- Other
- Action
- Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.
- Quantity
- 22 US and 147 international.
- Distribution
- Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K953896"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3002794293
- Firm city
- Troy
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28