Medtronic Vascular recalls SHERPA NX Active Guiding Catheters with potential for stainless steel wire exposure. Affected units have specific model and lot numbers. Contact for return instructions.
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. This could cause serious complications during medical procedures if the catheter is used improperly.
The catheter's primary segment material may break off, exposing the underlying stainless steel braid wires. This could lead to complications like kinks, blockages, or tissue damage during procedures.
Healthcare professionals using the catheter for cardiovascular procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used incorrectly.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F CHAMP1.5, diameter .070", and reference number SA6CHAMP15. The product was sold with specific lot and serial numbers.
Identify the model, size, and reference number to confirm if your catheter is affected.
Reach out to Medtronic Vascular for specific return or repair instructions.
The recall indicates a potential risk, so affected units should not be used until contacted by Medtronic Vascular.
Contact Medtronic Vascular directly to determine the next steps for affected units.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F CHAMP1.5, diameter .070", and reference number SA6CHAMP15.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2691-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2691-2019 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.
