Medtronic recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure. Affected units may have stainless-steel braid wires exposed, risking injury during cardiovascular procedures.
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 because a subset may have exposed stainless-steel wires. This could cause injury if the catheter is used improperly.
The catheter's primary segment material may wear away, exposing the underlying stainless-steel braid wires. This could cause injury if the catheter is moved or manipulated during a procedure.
Cardiovascular doctors and medical staff who use the recalled catheters are most at risk. Patients undergoing procedures with these catheters could also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH' on the product. The recall covers all units with this specific model and lot/serial numbers.
Identify the model and lot/serial numbers to confirm if your catheter is affected.
The recall states that a subset of these catheters may have exposed wires, so they are not safe for use without checking the model details.
The recall does not specify a remedy, so contact Medtronic Vascular directly to check if your catheter is affected.
Look for the model name 'SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH' on the product label.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2656-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2656-2019 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.