FDA designates recall of ICD as class 1
The FDA has designated Abbott’s product recall of an implantable cardioverter defibrillator as a class 1 recall, the most serious kind. The recall affects 108 devices manufactured and distributed between April 5 and June 14.
Electrical failures in the ICD (Ellipse), used in patients with bradycardia, tachycardia or HF, may cause the exposure of aluminum wires, according to a MedWatch report from the FDA. Electrical shorting of the capacitor may occur as a result of aluminum wires that are not completely insulated, leading to the inability to deliver high voltage therapy to the patient.
No methods or procedures are currently available to determine which devices are affected by this issue before failure, according to the report.
Abbott has not received any reports of failure associated with the affected devices. No deaths, patient harm or adverse events have been reported to the company. Thirty-one of the recalled devices have been implanted into patients.
The company distributed a notice to customers on June 21 alerting them to review device model and serial numbers and to identify any patients who may be affected, according to the report. Abbott will work with customers on obtaining replacements for patients who have received recalled devices.