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BRIEF-FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated In March 2019 As Class I Recall

Reuters logo Reuters 10/9/2019

Oct 9 (Reuters) - Medtronic PLC:

* FDA CLASSIFIES MEDTRONIC SHERPA DELIVERY CATHETER FIELD ACTION INITIATED IN MARCH 2019 AS CLASS I RECALL

* MEDTRONIC - FDA CLASSIFIED VOLUNTARY FIELD ACTION INITIATED IN MARCH 2019 RELATED TO 6F SHERPA NX ACTIVE CORONARY GUIDE CATHETER AS A CLASS I RECALL

* MEDTRONIC PLC - RECALL DOES NOT AFFECT MEDTRONIC LAUNCHER CORONARY GUIDE CATHETER OR OTHER MEDTRONIC CORONARY STENTS, BALLOONS OR IMPLANTABLE DEVICES

* MEDTRONIC PLC - IN RESPONSE TO RECEIVING SIX COMPLAINTS, MEDTRONIC CONDUCTED A THOROUGH INVESTIGATION OF CERTAIN LOTS OF PRODUCT

* MEDTRONIC PLC - DETERMINED THAT AFFECTED CATHETERS MAY HAVE A POTENTIAL TO LOSE OUTER MATERIAL FROM A DISTAL COMPONENT

* MEDTRONIC PLC - AFFECTED CATHETERS COULD RESULT IN UNDERLYING STAINLESS-STEEL BRAID WIRES BEING EXPOSED AFTER INSERTION

* MEDTRONIC PLC - HAS RECEIVED NO REPORTS OF PATIENT INJURIES

* MEDTRONIC PLC - HAS RECEIVED NO REPORTS OF PATIENT INJURIES ASSOCIATED WITH THIS ISSUE

* MEDTRONIC PLC - AS A PRECAUTION, MEDTRONIC HAS VOLUNTARILY RECALLED ALL MODELS OF 6F SHERPA NX ACTIVE CATHETERS DUE TO POTENTIAL PATIENT RISKS Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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