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. The catheters may expose underlying steel wires, which could cause serious injury if the catheter moves during use.
The catheter's outer layer may break off, exposing the steel wires inside. If the catheter moves during a procedure, these wires could cause injury to blood vessels or tissues.
Cardiovascular doctors and medical staff who use these catheters for procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F MAC3.0 30o, .070", and reference number SA6MAC3030. The product was sold with GTIN 00613994821737.
Identify the model, size, and reference number to confirm if your catheter is recalled.
The recall states there is a potential risk of wire exposure, so it is not safe to use without checking if it's recalled.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F MAC3.0 30o, .070", and reference number SA6MAC3030.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2694-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2694-2019 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.