May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports of injury, and one 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 several 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, myocardial infarction and death.
The U.S. Food and Drug Administration (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.
Abbott began contacting customers in March who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.
The recalled products include:
• Abbott NC Trek RX Coronary Dilatation Catheter
• Abbott NC Traveler Coronary Dilatation Catheter
• Abbott NC Tenku RX PTCA Balloon Catheter
Specific lots of affected product were manufactured between Jan. 1, 2015 – Jan. 2, 2017, and were distributed between Jan. 13, 2015 – March 14, 2017. Click on the specific catheter links above to see which lots were recalled.
Abbott said the specified balloons may exhibit difficulty in removing the protective balloon sheath, which can result in issues with inflating or deflating the balloon. The worldwide frequency of tight sheath removal, inflation and deflation reported events is 0.12 percent, the company said. In one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death.
Abbott said this recall does not affect patients having successfully undergone cardiac procedures using these devices.
On March 22, 2017, Abbott sent a Field Safety Notice letter to healthcare providers and risk managers informing them of the device's risks, and corrective actions that would be implemented to ensure ongoing product performance. The letter asked providers and risk managers to immediately stop using the devices from the identified lots and remove or quarantine them. The vendor also said providers could contact Abbott Vascular to obtain a return authorization number to return all affected and unused products to the company.
Abbott also asked providers to acknowledge receipt of the notification by returning the "Effectiveness Check Form" provided by Abbott Vascular by email to: [email protected], or via fax at (951) 914-5951.
Abbott's coronary dilatation catheters are indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, coronary artery occlusion in patients with ST-segment elevation myocardial infarction (STEMI), and balloon dilatation of a stent after implantation (2-5 mm balloon models only).
Customers with questions may contact their local Abbott Vascular representative, or contact Abbott's customer service department at (800) 227-9902.
For more information: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm559603.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery