Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F MAC 3.5) due to potential loss of primary segment material exposing steel wires. Affected units have specific model and lot numbers.
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 certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures. The catheters could have internal material failing, exposing steel wires that might cause complications during use.
The catheter's primary segment material could break off, exposing the underlying stainless-steel braid wires. This might cause damage to blood vessels or other complications during procedures.
Healthcare professionals using the catheters for cardiovascular procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. The product has a specific GTIN: 00613994821768 and all lot/serial numbers.
Identify the model SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. with GTIN 00613994821768.
The recall indicates a potential risk, so users should check if their catheter matches the recalled model and follow the action steps.
The official recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. with GTIN 00613994821768 and all lot/serial numbers.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2675-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2675-2019 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.
