Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F) due to potential loss of primary segment material exposing stainless-steel wires. Affected units have specific model and serial numbers.
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 because it could expose thin stainless-steel wires inside the device. This risk might cause serious complications during medical procedures if the catheter is used improperly.
The catheter's primary segment material could break off during use, exposing the internal stainless-steel braid wires. This might cause damage to blood vessels or other complications during procedures.
Cardiovascular doctors and medical staff who use the recalled catheter for procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used incorrectly.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII' on the device. The product was sold with specific lot and serial numbers.
Look for the model name and serial number on the catheter to confirm if it's affected.
The recall states there is a potential risk, so it's not safe to use without checking if it's affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII' on the device.
The recall doesn't specify a remedy, so contact Medtronic Vascular directly for guidance.
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-2727-2019 — 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-2727-2019 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.