Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible 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 cardiovascular procedures due to a potential risk of stainless steel wires becoming exposed. This could lead to complications during medical procedures if the catheter is used improperly.
The catheter may lose its primary protective layer, exposing the underlying stainless steel wires. This could cause injury to the patient's blood vessels or other complications during the procedure if the wires are not properly contained.
Cardiovascular doctors and medical professionals who use the recalled catheters for procedures. Patients receiving these catheters during treatment may be at risk if the catheter is used without proper safety checks.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR4.0, diameter .070", and reference number SA6JR40. The product was sold with GTIN 00613994822338.
Identify the model, size, and reference number to confirm if your catheter is recalled.
The recall indicates a potential risk, so it is not recommended for use until the remedy is applied. The manufacturer has not provided a specific remedy for this issue.
Look for the model 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR4.0, diameter .070", and reference number SA6JR40. The product was sold with GTIN 00613994822338.
The manufacturer has not provided a specific remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2618-2019 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.
