Medtronic recalls specific SHERPA NX Active Guiding Catheters due to potential exposure of stainless steel wires. Affected units have a unique reference number and were sold for cardiovascular procedures.
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 that may expose underlying steel wires during use. This could cause serious complications if the catheter is used improperly in cardiovascular procedures.
The catheter's primary segment material may break off during use, exposing the stainless-steel braid wires. This could lead to complications like kinking, blockages, or damage to blood vessels if the wires become trapped.
Cardiovascular professionals who use the recalled catheters for procedures are most at risk. Patients undergoing these procedures may also be affected if the catheter is used without proper safety checks.
Check for the reference number SA6SAL75SH on the catheter packaging or label. The catheter is designed for cardiovascular procedures and has a specific size (6F, .070").
Verify the reference number SA6SAL75SH on the catheter or packaging to confirm if it's affected.
The recall states that a subset of these catheters may expose steel wires, so they should not be used without checking the reference number.
Look for the reference number SA6SAL75SH on the catheter or packaging. The catheter is designed for cardiovascular procedures and has a specific size (6F, .070").
The recall does not specify a remedy, so contact Medtronic Vascular directly to confirm if your catheter is affected.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2708-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2708-2019 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.