Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F 100CM 3DRC) due to potential loss of primary segment material exposing stainless-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 for cardiovascular use. The recall is because a subset of these catheters might have primary segment material that could be lost, exposing underlying stainless-steel wires. This could lead to serious complications during medical procedures.
The catheter's primary segment material might be lost during use, exposing the stainless-steel braid wires. This could cause damage to blood vessels or other complications during medical procedures.
Cardiovascular doctors and medical professionals who use the recalled catheters for procedures. Patients undergoing procedures with these catheters are at risk if the catheter is defective.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, length 100CM, and reference number SA63DRCSH. The product was sold with specific lot and serial numbers.
Identify the model, size, length, and reference number to confirm if your catheter is affected.
The recall is due to a potential loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Check the product details to see if it matches the recalled model. If it does, contact Medtronic Vascular for further instructions.
The recall states there is a potential for extensive loss of primary segment material exposing wires, which could lead to complications during procedures.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2610-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2610-2019 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.