FDA has designated as Class I a Medtronic recall involving the company’s FlexCath Select Steerable Sheath (10 Fr Select).
The single-use device is used for percutaneous catheter introduction into the vasculature and chambers of the heart. Medtronic has used its FlexCath sheaths with its Arctic Front Advance Cryoballoon System that freezes tissue inside the heart to treat abnormal heart beat.
Medtronic initiated the recall last month after four reports of clinicians observing debris appearing to originate from the hemostasis valve on the proximal end of Model 990065 of the device, according to FDA.
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