These catheters used in heart surgery have caused 9 injuries. They’ve been recalled
The FDA has issued a MedWatch Safety Alert for patients and healthcare professionals about a catheter used in heart surgeries that has caused nine injuries.
Boston Scientific recalled 12 lots of its Imager II 5F Angiographic Catheters because, according to the recall notice, the tip has a habit of detaching. The catheters can break during surgery prep or during cardiac surgery.
That can “lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital,” the notice says. “There is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death.”
So the FDA put a Class I designation on this recall, meaning “use of these devices may cause serious injuries or death.”
This covers lot Nos. 132355; 132447; 132823; 133447; 133448; 133737; 134011; 134092; 134600; 134631; 134946; and 139512.
Healthcare professionals with questions can email BSCFieldActionCenter@bsci.com or talk to their local sales representative. Patients or professionals also can report a bad experience to the FDA’s MedWatch reporting program .
