FDA product code PYX: Temporary Non-Roller Type Right Heart Support Blood Pump

PYX is the FDA product code for temporary non-roller type right heart support blood pump. It is a Class III device, regulated under 21 CFR 870.4360 and reviewed by the Cardiovascular panel. Devices under PYX reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 7 recalls for PYX devices, 7 initiated in the last five years.

Definition

Providing temporary partial or full right heart circulatory support.

Classification

Recalls for PYX devices

7 product recalls in 4 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-01-27.

Frequently asked questions

What is FDA product code PYX?

PYX is the FDA product code for temporary non-roller type right heart support blood pump. It is a Class III device, regulated under 21 CFR 870.4360 and reviewed by the Cardiovascular panel.

What device class is PYX?

Class III, regulation 21 CFR 870.4360. Typical premarket route: PMA.

Have PYX devices been recalled?

Yes: 7 product recalls across 4 recall events; the most recent began 2026-01-27.

Next steps

• Run an FDA pathway report with predicate devices for product code PYX
• Run a recall and safety report across every PYX manufacturer
• Watch product code PYX for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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