# P890055: Medstream Programmable Infusion Pump System

- Pathway: PMA
- Applicant: Intera Oncology
- Decided: Mar 11, 1996 after 2,356 days
- Product code: LKK (Pump, Infusion, Implanted, Programmable)
- Device class: 3
- Recalls of this device: 15 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 11, 2026 · Class II · Z-2580-2026: There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
- Jul 10, 2022 · Class I · Z-1522-2022: Higher than expected flow rate.
- Nov 10, 2015 · Class II · Z-1571-2014: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
- Nov 10, 2015 · Class II · Z-1572-2014: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
- Mar 5, 2015 · Class II · Z-1684-2015: Needle is leaking from hub/needle cannula connection
- Aug 13, 2013 · Class I · Z-2300-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2295-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2296-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2299-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2297-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2298-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2293-2013: Drug flow rates exceeding programmed flow rates.
- Aug 13, 2013 · Class I · Z-2294-2013: Drug flow rates exceeding programmed flow rates.
- Jun 7, 2013 · Class I · Z-1690-2013: Miscalibrated Fill Level Sensor may affect dosing level
- Jun 7, 2013 · Class I · Z-1691-2013: Miscalibrated Fill Level Sensor may affect dosing level

Source page: https://510kreport.com/device/P890055
Methodology: https://510kreport.com/methodology