Venture Catheters Recalled Due to Potential Risk of Embolism, Injury
There may be excess material present inside part of the device tip
Vascular Solutions has recalled 4,679 units of Venture Catheters due to a possible risk of embolism and injury.
There may be excess material inside the inner lumen of the distal catheter tip. This material can separate from the catheter while in use and pose a possible risk of embolism, which may result in a serious injury.
The affected devices were distributed throughout the U.S. and include all unexpired lots of the Rapid Exchange, Over-the-Wire, and Coronary Sinus catheters.
For a full list of the affected product codes and lot numbers, see the official release issued by the U.S. Food and Drug Administration (FDA).
The company began the recall by sending an Urgent Medical Device Recall notification to those who had bought the impacted catheters. Any healthcare facility with one of these devices should take them out of its inventory and return them to Vascular Solutions.
For more information, consumers can reach Vascular Solutions at (888) 240-6001.