Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER models with potential for stainless-steel wire exposure. Learn what to do if affected.
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 internal wires becoming exposed, which could cause serious complications. This recall affects certain models sold for medical use.
The catheter's primary segment material can become exposed, revealing stainless-steel braid wires. This could lead to complications like tissue damage or blockages during procedures.
Healthcare professionals using the SHERPA NX ACTIVE GUIDING CATHETER for cardiovascular procedures are most at risk. Patients receiving this catheter during procedures may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F EBU3.5, diameter .070", and reference number SA6EBU30. The product was sold for cardiovascular use with GTIN 00613994823625.
Verify the model, size, and reference number against the list provided in the recall notice.
The recall indicates a potential risk, so healthcare professionals should check if they have the affected model before use.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F EBU3.5, diameter .070", and reference number SA6EBU30.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2622-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2622-2019 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.