Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER 6F MB1 models due to potential loss of primary segment material exposing stainless-steel wires. Affected units may require medical evaluation.
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 specific SHERPA NX ACTIVE GUIDING CATHETER models used in cardiovascular procedures. The recall is due to a risk of internal wire exposure that could cause complications during medical procedures.
The catheter's primary segment material can become exposed, potentially releasing stainless-steel braid wires. This could cause tissue damage or complications during medical procedures if the wires interact with the body.
Healthcare professionals using the catheter for cardiovascular procedures are most at risk. Patients undergoing procedures with these catheters may also be affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. All units sold with GTIN 00613994821966 are affected.
Identify the model and serial number to confirm if your catheter is affected.
The recall states there is a potential risk of wire exposure, so affected units should not be used until further instructions are received.
Contact Medtronic Vascular directly to confirm if your specific model is affected and follow their guidance.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1 with GTIN 00613994821966.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2646-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2646-2019 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.
