A leak risk in the part packed with every pump — eight in ten device records are Class II, and this is the other two (Abiomed)

1The Impella and its introducer

The Impella is a device placed inside the heart via catheter that pumps blood to support a weakened heart. To bring the device into the vessel, a sheath called an introducer is first inserted into the blood vessel, and the catheter is then advanced through it.

The introducer is not the device itself but the pathway to it — yet because it sits in a large vessel, leakage from it connects directly to problems such as bleeding or air entry.

2Where the leakage can occur

The defect here is a potential for leakage from under the sheath cap and along the hub score lines — the scored grooves on the connector at the operator's end. What FDA records treat as especially weighty is the explicit statement that this manufacturing issue is not visually detectable by the user. In other words, inspecting the exterior before use does not let a clinician identify an affected unit.

3Why every pump set is affected

Further, a 14 Fr or 23 Fr introducer is described as being provided in every pump set.

That means the issue is not confined to one separately sold component but reaches across the product line — which is the background to a recall quantity of 87,277 units and distribution spanning U.S. nationwide plus Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, and many other countries.

4Why it matters

5Eight in ten device records are Class II

Sorting the 779 device records this site holds as of 2026-09-01 by classification gives 137 in the most serious Class I and 642 in Class II.

Eight in ten are Class II, and this record falls in the other two. Most device recalls concern faults that amount to inconvenience in use. Class I attaches where, as here, the fault reaches a component used on a path into the body or in sustaining life.