Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk. Learn product details and safety steps.
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 certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures. The recall is due to a potential risk of internal wires becoming exposed, which could cause complications during medical procedures.
The catheter's primary segment material could become exposed, revealing stainless-steel braid wires. This might lead to complications during procedures, such as unintended tissue damage or kinking of the catheter.
Healthcare professionals using the catheter for cardiovascular procedures are most at risk. Patients undergoing procedures with this specific catheter model may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, EBU3.5, 90CM.070", and reference number SA6EBU35D. The product was sold with a specific GTIN: 00613994823571.
Identify the model, size, and reference number to confirm if your catheter is affected.
The recall states there is a potential risk of wire exposure, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, EBU3.5, 90CM.070", and reference number SA6EBU35D.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-2577-2019 — Medtr: a short, human brand name for headings (e.g. "Trsmima") Medtr: a short, human brand name for Hello, I own a Medtr: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-2577-2019 from Medtr: a short, human brand name for headings (e.g. "Trsmima"). 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.