- Abbott’s recall of its Amplatzer Steerable Delivery Sheath was categorized by the Food and Drug Administration as a Class I event.
- Abbott asked customers to return any unused sheaths last month after receiving 16 injury reports linked to the cardiac catheter. The injuries, plus another 10 incidents, were associated with an increased risk of air bubbles.
- Bubbles, also known as air emboli, can lead to sudden reductions in blood flow to the heart, low blood pressure and insufficient blood oxygen. The severity of the effects led the FDA to class the problem as its most serious type of recall.
Physicians insert the recalled device through the skin to provide a pathway for catheter-based devices to be introduced into the chambers of the heart. While the sheath is used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder, an implant designed to prevent blood clots from forming in patients with a heart arrhythmia, that device is unaffected by the recall.
Abbott calculated a reported incidence rate of 0.77% related to “observed or potential” air embolism in procedures using the delivery sheath. In some cases, the air bubbles resulted in transient ST segment elevation, a sign of sudden reduction in the blood flow to the heart. The ST elevations resolved spontaneously. Less commonly, patients suffered hemodynamic instability that required medical intervention.
Air ingress is a known risk with the device that is addressed in the instructions for use. The existing instructions state “that the hemostasis valve in the closed position minimizes blood loss but does not prevent air ingress” and provide details of how to reduce the risk.
However, with air ingress continuing to happen despite the instructions, Abbott has decided to recall the devices. The company plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.
No patients had permanent injuries or died as a result of the air emboli. The air bubbles could cause serious events including stroke and death, and as such the FDA assigned the recall to Class I, its highest risk category.