Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters 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 underlying stainless steel wires. This could lead to injury if the wires are accidentally manipulated during medical procedures.
Cardiovascular doctors and medical staff using the recalled catheters are most at risk. Patients undergoing procedures with these catheters may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F ERAD LEFT, .070", and reference number SA6ERADL. The product was sold with specific lot and serial numbers.
Identify the model, size, and reference number to confirm if your catheter is affected.
The recall indicates a potential risk, so affected units should not be used until the remedy is applied.
Check the product details to confirm if it's affected; if so, contact Medtronic Vascular for guidance.
The recall record does not specify a remedy, so contact Medtronic Vascular directly for assistance.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2627-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2627-2019 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.