Medtronic Vascular recalls SHERPA NX 6F catheters 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 Vascular is recalling a specific type of cardiovascular catheter because a small section of the catheter could expose underlying steel wires. This poses a risk of injury during medical procedures if the catheter is used improperly.
The catheter's outer layer could become damaged, exposing the inner steel wires. If these wires are accidentally moved during a procedure, they might cause injury to the patient or the medical staff.
Cardiovascular doctors and medical staff who use the SHERPA NX 6F catheter for procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. on the catheter or packaging. The product was sold with a specific GTIN: 00613994823922.
Look for the model number SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. on the catheter or packaging.
The recall states there is a potential risk of wire exposure, so it is not safe to use without checking if it is affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. on the catheter or packaging. The product was sold with GTIN: 00613994823922.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2569-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2569-2019 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.