The FDA today issued a notice warning of a recall of arterial perfusion cannula devices made by Edwards Lifesciences (NYSE: EW).
Edwards offers its arterial perfusion cannulae for adult patients undergoing cardiopulmonary bypass. They provide arterial perfusion of oxygenated blood in the extracorporeal circuit for up to six hours.
The company identified occurrences in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip of the OptiSite arterial perfusion cannula devices, was found to be exposed (released from the cannula body). Edwards also makes some models of its femoral arterial cannula devices with the same components as the impacted devices. It included those models as affected product that customers should remove from use.
According to the FDA notice, the recall involves removing devices from use and sale. The agency identified it as the most serious kind of recall.
Risks may include major tissue damage, puncturing the artery which could cause bleeding, inadequate perfusion and hemolysis. As of May 20, 2025, Edwards Lifesciences reports no serious injuries or deaths associated with this issue.
Edwards issued a field corrective action recommending that customers remove the affected product from their inventory.
List of affected products:
| OptiSite Arterial Perfusion Cannula | OPTI16 | 00690103180558 |
| OptiSite Arterial Perfusion Cannula | OPTI18 | 00690103180565 |
| Peripheral Femoral Arterial Cannula | FEMII016A | 00690103031232 |
| Peripheral Femoral Arterial Cannula | FEMII016AS | 00690103168341 |
| Peripheral Femoral Arterial Cannula | FEMII018A | 00690103031256 |
| Peripheral Femoral Arterial Cannula | FEMII018AS | 00690103168358 |
