Pyng Medical has initiated a voluntary recall of the first 400 FASTx Sternal Intraosseous Devices shipped to distributors, after receiving feedback regarding inconsistent performance in several early training sessions.
During this period of FASTx evaluation, the FAST1 continues to ship to customers desiring the benefits of sternal IO, anatomical land marking, automatic depth control, and secure placement.
The clinical benefits available through utilisation of the FAST1 Sternal Intraosseous Device will not be impacted by this voluntary action, Pyng Medical said.
Pyng president and CEO Mark Hodge said that this voluntary recall was initiated because it is simply the right thing to do when there is any question regarding the performance of a medical device.
“The Pyng technical team is working rapidly to analyse these events and determine a course of action. We will ensure that the FASTx Sternal Intraosseous Device is performing as we expect it to perform and will provide ongoing updates,” Hodge said.
Pyng has discontinued shipment of future devices until it can evaluate these happenings and determine root cause.