FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event
According to a news release on medtechdive.com, the U.S. Food and Drug Administration (“FDA”) has categorized the Cordis Vascular Visualization Catheter recall as a Class I event after the agency found out that the eight injuries have been linked to the device’s defect.
The recall states that Cordis has already warned medical professionals not to use the affected catheter devices in procedures because pieces of the device break and could become trapped between the vessel wall and endovascular devices. If the device breaks, the catheter might stretch during its removal and cause marker bands to dislodge or move, resulting in injury to the patient.
The FDA’s Class I recall follows decades of reports alleging Cordis Vascular Visualization Catheters have a defect in which marker bands might dislodge into the vascular system as the catheter is stretched. Cordis, a is subsidiary of Johnson & Johnson, when the company acquired Cordis from Cardinal Health.
This Class I notice applies only to Vascular Visualization Catheters distributed from 2019 until July 20, 2021, and only applies to a risk of the device’s marker bands dislodging if the catheter becomes trapped. According to the report, when a surgeon tries to remove the trapped catheter, the catheter stretches, causing the marker bands to move. So far, the FDA is only aware of 167 complaints and 8 injuries.
The announcement reports that dislodged marker bands could damage the vasculature, delay procedures, require surgery, cause strokes, heart attacks, or lead to blood vessel blockages in the lungs. These potential health events have led the FDA to place the recall into its highest risk category.
Cordis has warned medical professionals not to use the affected catheter device in procedures that risk the catheter becoming trapped. Moreover, Cordis also cautioned physicians about reading the device’s instructions that warn about the catheter stretching. Cordis has deduced that the adverse events are not associated with any manufacturing defect.
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