Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure. Affected units may have stainless-steel braid wires exposed, risking injury during 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 Vascular is recalling a specific type of cardiovascular catheter due to a risk of stainless-steel wires becoming exposed, which could cause injury during medical procedures. This recall affects catheters with the model number SA6CHAMP10SH.
The catheter's primary segment material can become exposed, revealing stainless-steel braid wires. This could lead to injury if the wires are accidentally contacted during medical procedures.
Cardiovascular doctors and medical staff who use the recalled catheters are most at risk. Patients receiving procedures with these catheters may also be affected.
Check for the model number SA6CHAMP10SH on the catheter. The catheter is designed for cardiovascular use and has a GTIN of 00613994823403. All lot and serial numbers are included in the recall.
Identify the model number SA6CHAMP10SH on the catheter to confirm if it is affected.
The recall indicates a potential risk, so affected catheters should not be used until the manufacturer provides a remedy.
Look for the model number SA6CHAMP10SH on the catheter. The catheter is designed for cardiovascular use and has a GTIN of 00613994823403.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2695-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2695-2019 from Medtr: 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.
