FDA Class I recall: leakage risk in the introducer supplied with every Impella heart pump set (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

This case shows how an accessory that delivers a device into the body — rather than the headline device itself — can govern overall safety. Where a defect cannot be screened visually, identification depends entirely on matching identifiers. FDA records specify pump set code 0048-0003, introducer product code 0052-3046, GTIN 00813502012279 and 00813502011876, and state that all current batches in the field are affected.