Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk during cardiovascular procedures. Affected units have a potential for stainless steel wires to become exposed.
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 used in cardiovascular procedures. The catheters could expose underlying stainless steel wires, which might cause complications during medical procedures.
The catheter's primary segment material could become exposed, revealing stainless steel braid wires. This might lead to complications during procedures, such as unintended tissue damage or kinking of the catheter.
Cardiovascular doctors and medical staff who use the recalled catheters for procedures. Patients undergoing these procedures may be at risk if the catheter is used without proper safety checks.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. The product was sold with GTIN 00613994823205 and all lot/serial numbers.
Identify the model SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. with GTIN 00613994823205.
The recall is due to a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of these catheters.
The official notice does not specify a remedy or action for affected users.
The recall states there is a potential for complications during procedures, but does not specify the risk of serious injury.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2712-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2712-2019 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.
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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.
