Jostra Hl-20 Integrated Perfusion System

510(k) K943803

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK943803	Date30 Jan 1996Cleared	StatusActive

5 recalls · FDA

- Terminated Z-3057-2011 FDA Unclassified (pre-2012) initiated 20 Jun 2011
HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.
- Terminated Z-3084-2011 FDA Unclassified (pre-2012) initiated 20 Jun 2011
Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
- Terminated Z-1394-2011 FDA Unclassified (pre-2012) initiated 28 Sep 2010
A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
- Terminated Z-0159-2007 FDA Unclassified (pre-2012) initiated 3 Oct 2006
The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
- Terminated Z-0158-2007 FDA Unclassified (pre-2012) initiated 1 Sep 2006
The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

1 jurisdiction

United States — FDA 510(k) Active

510(k)