Medtronic recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure risk during cardiovascular 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 is recalling certain SHERPA NX Active Guiding Catheters used in heart procedures. The catheters could expose internal steel wires, which might cause serious complications during medical procedures.
The catheter's primary segment material could break off, exposing the underlying steel wires. This might cause injury to blood vessels or tissue during procedures, leading to serious complications.
Cardiovascular doctors and medical staff who use the recalled catheters for procedures. Patients undergoing these procedures are at risk if the catheter is used incorrectly.
Check for the model: SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. The product was sold with GTIN: 00613994822574. All lot and serial numbers are included in the recall.
Verify the model number and GTIN to confirm if your catheter is recalled.
The recall indicates a potential risk, so it's not safe to use without checking the recall details.
Check the product details against the recall list to see if it's affected; the recall does not specify a remedy.
The recall does not mention a remedy or replacement process.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2637-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2637-2019 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.
