Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER model 6F HSII SH for potential wire exposure. Affected units may have stainless steel wires exposed, risking injury during 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 Vascular is recalling a specific type of cardiovascular catheter due to a risk of stainless steel wires becoming exposed, which could cause injury during medical procedures. This recall affects certain models sold with specific serial numbers.
The catheter's primary segment material can become exposed, revealing stainless steel braid wires. This exposure could lead to injury if the catheter is used during procedures without proper safety checks.
Cardiovascular doctors and medical staff who use the recalled catheter during 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 model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F HSII SH, and serial number starting with 'SA6HSIISH'. The product was sold for cardiovascular use with specific serial numbers.
Identify the model, size, and serial number to confirm if your catheter is affected.
The recall indicates a potential risk of wire exposure, so it is not safe to use without checking if it is affected.
Check the model, size, and serial number to see if it is affected by the recall. If it is, contact Medtronic Vascular for further instructions.
Look for the model 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F HSII SH, and serial number starting with 'SA6HSIISH'.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2683-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2683-2019 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.