Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F JR3.5, .070", REF SA6JR35) due to potential loss of primary segment material exposing stainless-steel wires. This could cause complications 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 Vascular is recalling SHERPA NX Active Guiding Catheters (6F JR3.5, .070", REF SA6JR35) because a subset may have primary segment material that could be lost, exposing stainless-steel wires. This risk could lead to complications during cardiovascular procedures.
The catheter's primary segment material could be lost during use, exposing the underlying stainless-steel braid wires. This could cause complications during cardiovascular procedures, such as kinking or blockages.
Cardiovascular professionals who use these catheters for procedures are likely affected. Patients undergoing procedures with these catheters may be at risk if the catheter is recalled.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. The product was sold with GTIN: 00613994822390 and all lot/serial numbers.
Identify the model SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35 with GTIN 00613994822390.
The recall is due to a potential loss of primary segment material exposing stainless-steel braid wires on a subset of these catheters, which could cause complications during cardiovascular procedures.
The official recall notice does not specify a remedy, so contact Medtronic Vascular directly for guidance.
The recall states a potential for complications during procedures, but does not specify a risk of serious injury or death.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-2643-2019 — Medtr: a short, human brand name for headings (e.g. "Trsmima") Medtr: a short, human brand name for Hello, I own a Medtr: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-2643-2019 from Medtr: a short, human brand name for headings (e.g. "Trsmima"). 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.
