Cook—Pericardiocentesis Catheter Sets and Trays and Thoracentesis Sets: Catheter Distal End Hole May Be Too Small

April 17, 2019 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an April 9, 2019, Urgent Medical Device Recall letter submitted by ECRI Institute member hospitals, Cook states that the above catheters may have been manufactured with a distal end hole that is too small to be used with the intended size 0.038-inch wire guide. Cook also states that this problem could lead to a delay in procedure, prolonged procedure, and additional intervention. It is possible that organ or vessel injury could occur during manipulation of the...

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