FDA product code OZD: Temporary Non-Roller Type Left Heart Support Blood Pump

OZD is the FDA product code for temporary non-roller type left heart support blood pump. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OZD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 47 recalls for OZD devices, 43 initiated in the last five years.

Definition

A blood pump that provides temporary full or partial left heart support

Classification

Recalls for OZD devices

47 product recalls in 22 recall events; 43 initiated in the last five years and 43 still open. Most recent: 2026-08-12.

Frequently asked questions

What is FDA product code OZD?

OZD is the FDA product code for temporary non-roller type left heart support blood pump. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is OZD?

Class III. Typical premarket route: PMA.

Have OZD devices been recalled?

Yes: 47 product recalls across 22 recall events; the most recent began 2026-08-12.

Next steps

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