Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk during cardiovascular procedures. Affected units have a unique reference code SA6EBU35.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Medtronic is recalling certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures because a small section of the catheter could break off, exposing metal wires. This could cause serious injury during medical procedures if the catheter breaks inside a patient's blood vessels.
The catheter's outer layer may break off during use, exposing the internal metal wires. This could cause the wires to move inside blood vessels, potentially causing injury or blockage during a procedure.
Healthcare professionals using the catheter for cardiovascular procedures are most at risk. Patients undergoing procedures with these catheters could be affected if the catheter breaks during treatment.
Check for the reference code SA6EBU35 on the catheter packaging or label. The catheter is used for cardiovascular procedures and has a specific size (6F EBU3.5, .070").
Look for the reference code SA6EBU35 on the catheter packaging or label to confirm if it's affected.
The recall is for a potential risk of the catheter's outer layer breaking off, which could expose metal wires inside the blood vessels during procedures.
Check for the reference code SA6EBU35 on the catheter packaging or label to confirm if it's affected. If it is, contact Medtronic for further instructions.
Yes, if the catheter breaks during a procedure, it could cause injury to blood vessels or block blood flow.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2617-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2617-2019 from Medtronic Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
