Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F, EBU4.0, 110cm) due to potential exposure of stainless steel wires. Affected units may have risk of 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 certain SHERPA NX Active Guiding Catheters for cardiovascular use. The catheters could expose underlying stainless steel wires, potentially causing injury during medical procedures.
The catheter's primary segment material could break off, exposing the stainless steel braid wires. This may cause injury during medical procedures if the wires become tangled or kinked.
Cardiovascular doctors and medical staff using the recalled catheters for procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model: SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. The product was sold with GTIN: 00613994823519. All lot/serial numbers are affected.
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 affected units should not be used until the remedy is applied.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Check for the model: SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. The product was sold with GTIN: 00613994823519.
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-2578-2019 — 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-2578-2019 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.