Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F MAC3.5 SH) due to potential exposure of stainless steel wires. Affected units have specific model and serial numbers.
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 Vascular is recalling a specific type of cardiovascular catheter that may expose underlying steel wires, risking injury during procedures. This recall affects medical devices used in hospitals and clinics.
The catheter's outer layer may break during use, exposing thin stainless steel wires that could cause injury to blood vessels or tissue. This risk is higher in procedures requiring precise catheter placement.
Healthcare professionals using the catheter for procedures and hospitals that have the specific model. Patients undergoing procedures with this catheter are at risk if the device is used without proper safety checks.
Check for the model number 6F MAC3.5 SH, size .070", and reference SA6MAC35SH on the catheter or its packaging. The recall covers all units with this specific model and serial numbers.
Look for the model number 6F MAC3.5 SH, size .070", and reference SA6MAC35SH on the catheter or its packaging.
The recall states there is a potential for wire exposure, so it is not safe to use without checking the recall status.
Contact Medtronic Vascular directly to confirm if your specific unit is affected and follow their instructions.
Check for the model number 6F MAC3.5 SH, size .070", and reference SA6MAC35SH on the catheter or its packaging.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2676-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2676-2019 from Medtr: 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.