Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters due to potential exposure of stainless steel wires. Affected units may cause injury during procedures. Contact for return instructions.
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 due to a risk of stainless steel wires becoming exposed, which could cause injury during medical procedures.
The catheter's primary segment material may break off, exposing the underlying stainless steel braid wires. This could cause injury to the patient during medical procedures if the wires become exposed.
Healthcare professionals using the catheter for procedures are most at risk. Patients receiving the catheter during procedures may also be affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. The product was sold with a GTIN: 00613994823878 and all lot/serial numbers.
Identify the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. to confirm if it is affected.
The recall is due to a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
The official recall notice does not specify a remedy or action steps for affected units.
The recall indicates a potential hazard, so affected units should not be used until further instructions are received.
We’ve drafted a message you can send Medtr:Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2572-2019 — Medtr:Vascular Medtr:Vascular Hello, I own a Medtr:Vascular that is covered by recall Z-2572-2019 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.