The issue was discovered after the company received complaints about separation difficulties with the stent, which is indicated for use in patients with stenotic lesions of the carotid artery, and investigated the issue independently.
Cordis said it discovered that affected lots of the Precise stent system had an “increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment,” according to its urgent safety recall notice.
No patient injuries have been reported related to the shaft separation issue, Cordis said. The company warned that the malfunction could cause intra-procedural delay for the patient while a replacement device is prepped.
Cordis also warned against the possibility of vessel damage which would require unplanned percutaneous surgical intervention, and the possibility of transient ischemic attack or stroke in severe cases.
The company said it is recalling products manufactured between April 27, 2015 and November 22, 2015, which includes 16 catalog numbers and 179 lots.
Cordis advised affected users to identify affected units and return them. The company said it notified all appropriate regulatory bodies of the recall and separation issues.
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