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Medical Devices / Submissions and Approvals

Cook Medical Recalls Transseptal Needles

March 29, 2019
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Cook Medical recalled one lot of transseptal needles after a manufacturing error caused the needle tips to be produced without a back bevel.

The 97 recalled products have a sharp tip resulting from the missing back bevel, which could cause plastic fragments to break off during needle insertion and harm the patient.

The plastic fragments could enter a patient’s bloodstream during cardiac procedures, leading to serious adverse health consequences that include embolism, stroke, damage to blood vessel walls or death.

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