Abbott catheter voluntary recall
Abbott has initiated a voluntary recall of specific lots of three catheters due to 19 reports of injury, and 1 report of death associated with difficulty removing the protective balloon sheath, resulting in issues with inflating or deflating the balloon.
Abbott is recalling products from the identified lots because physicians may experience difficulty in removing the protective balloon sheath. This can result in issues with inflating or deflating the balloon during procedures and may cause serious adverse health consequences including: air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
132,040 devices have been recalled. They were made between January 1, 2015 to January 2, 2017.
Per the FDA website, “Abbott's Coronary Dilatation Catheters are indicated for use in the following cardiac procedures:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving blood flow to the heart;
• balloon dilatation of a coronary artery occlusion (blocked or clogged
artery), for the purpose of restoring coronary blood flow in patients with ST-segment elevation myocardial infarction (heart attack); and • balloon dilatation of a stent after implantation (2.00 mm - 5.00 mm balloon models only).”
On March 22, 2017, Abbott sent a "Field Safety Notice" letter to health care providers and risk managers informing them of the device's risks, and corrective actions that would be implemented to ensure ongoing product performance.
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