Medtronic recalls specific SHERPA NX Active Guiding Catheters for 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 used in cardiovascular procedures. The catheters could expose underlying steel wires, which might cause injury if the device moves during use.
The catheter's primary segment material may break off, exposing the stainless-steel braid wires. If the wires move during use, they could cause injury to blood vessels or tissue.
Cardiovascular professionals using the recalled catheters are most at risk. Patients undergoing procedures with these catheters could be affected if the device malfunctions.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. The product was sold with GTIN 00613994822246 and all lot/serial numbers.
Identify the model SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. with GTIN 00613994822246.
The recall indicates a potential risk, so users should check if they have the affected model before use.
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. with GTIN 00613994822246.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2619-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2619-2019 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.
