Medtronic recalls SHERPA NX Active Guiding Catheters (6F SCR4.0) due to potential wire exposure. Affected units may have stainless steel wires exposed, risking injury during 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 for cardiovascular use because a subset may have exposed stainless steel wires. This could cause injury during medical procedures if the catheter is used improperly.
The catheter's primary segment material may break off, exposing the underlying stainless steel braid wires. This could cause injury to the patient or damage to the catheter during procedures if the wires are not properly protected.
Cardiovascular doctors and medical staff who use these catheters during procedures are most at risk. Patients receiving these catheters are also affected but typically under medical supervision.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40' on the product. The recall covers all units with this specific model and lot/serial numbers.
Look for the model number SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40 on the catheter or its packaging.
The recall states that a subset of these catheters may have exposed wires, so they are not safe for use without checking the model number and following the recall instructions.
Check for the model number SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40 on the product or its packaging.
The recall does not specify a remedy, so contact Medtronic Vascular directly to determine if your catheter is affected and get guidance.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2719-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2719-2019 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.
