According to the CNBC, the recall was issued Tuesday and involves the Agilis Steerable Introducer Sheath, a device used to insert and position cardiovascular catheters in the heart.
The FDA states that a valve on the device which is meant to prevent blood from flowing back through the device may be faulty and not fulfill its function.
Recalled units were manufactured and distributed between January 1 and May 5, 2017.
Recalls issued by the FDA fall under three classifications:
The FDA also recognized two other safety actions: