FDA posts early alert over device used with Impella heart pumps

Dive Brief:

Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.

Dive Insight:

The early alert applies to devices that physicians use to introduce catheters to the body. Abiomed includes the introducers in Impella pump sets and sells the devices in individual packaging. The portfolio features introducers with different specifications for Abiomed’s Impella RP and Impella CP devices.

Abiomed has identified a potential for introducer sheath leakage in 14 French- and 23 French-sized devices. Devices can leak from the sidearm, under the sheath cap and along the hub score lines. Abiomed attributed the leaks to manufacturing issues that increase the risk of access site bleeding, both when the device is inserted and during early manipulation.

Access site bleeding can require medical intervention, including the exchange or removal of the device, manual compression and blood transfusion, the FDA said. Life-threatening bleeding is possible, particularly in patients undergoing large-bore vascular access while receiving anticoagulants.

Abiomed had reported eight instances of major bleeding as of April 22. The company had reported three complaints that described patient deaths, although it determined the fatalities were not attributable to introducer leakage, according to the FDA notice.

The FDA’s early alert is part of a string of regulatory notices about Impella and associated devices, primarily the controllers physicians use to adjust and monitor the pumps. The agency published a recall notice about a correction for Impella heart pump controllers this month.

Abiomed’s manufacturing partner is involved in the introducer correction. Integer, a contract medical device manufacturer, acquired Oscor for $218 million in 2021. Oscor makes introducer systems, guiding sheaths and lead wires for use in electrophysiology, neurostimulation and cardiovascular procedures.