Medtronic recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure risk 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 due to a risk of internal wire exposure. This could lead to complications if the catheter is used improperly.
The catheter may lose its primary protective layer, exposing the underlying stainless-steel wires. This could cause tissue damage or other complications during procedures if the catheter is used without proper protection.
Cardiovascular professionals who use the recalled catheters 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 EBU4.0 SH, .070", REF SA6EBU40SH. The product was sold with GTIN: 00613994823496 and all lot/serial numbers.
Identify the model, size, and reference number to confirm if your catheter is recalled.
The recall indicates a potential risk, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. with GTIN: 00613994823496.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2629-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2629-2019 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.