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 heart procedures because a small section of the catheter could break off, exposing metal wires. This could cause serious injury if the broken piece moves inside the body.
The catheter's outer layer may break off during use, exposing the metal wires inside. If the broken piece moves inside the body, it could cause serious injury or block blood flow.
Cardiovascular doctors and medical staff who use the recalled catheters for procedures. Patients undergoing these procedures are at risk if the catheter is used without the recall fix.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR5.0 SH, .070", and reference number SA6JR50SH. The product was sold with GTIN 00613994821799.
Identify the model, size, and reference number to confirm if your catheter is recalled.
The recall indicates a potential risk, so it should not be used until the remedy is applied. The manufacturer has not provided a specific remedy in this record.
Look for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR5.0 SH, .070", and reference number SA6JR50SH.
The manufacturer has not provided a remedy in this record, 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-2713-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2713-2019 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.