Medstream 91-4285US

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

15 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10886704071457 UDI-DI	Date20 Sep 2014Listed	StatusListed GUDID: not in commercial distribution

15 recalls · FDA

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

1 jurisdiction

United States — GUDID listing Listed

GUDID