Medtronic recalls SHERPA NX Active Guiding Catheters (6F EBU4.5) due to potential wire exposure. Affected units may have stainless steel 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 is recalling certain SHERPA NX Active Guiding Catheters for cardiovascular use because a subset may have exposed stainless steel wires. This could cause injury if the catheter is used improperly during medical procedures.
The catheter's primary segment material may break off, exposing the underlying stainless steel braid wires. This could lead to injury if the wires cause tissue damage during procedures.
Cardiovascular doctors and medical staff who use the recalled catheters are most at risk. Patients receiving procedures with these catheters could also be affected.
Check for the model: SHERPA NX Active Guiding Catheter, 6F EBU4.5, .070", REF SA6EBU45. The product was sold with GTIN 00613994824639 and all lot/serial numbers.
Identify the model and serial number to confirm if your catheter is affected.
The recall states that a subset of these catheters may have exposed wires, so they are not safe for use without checking the specific model and serial number.
The recall does not specify a remedy, so contact Medtronic Vascular directly to check if your catheter is affected.
Look for the model: SHERPA NX Active Guiding Catheter, 6F EBU4.5, .070", REF SA6EBU45. The product was sold with GTIN 00613994824639 and all lot/serial numbers.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2633-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2633-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
