Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070" model for potential wire exposure. Learn if affected and what to do.
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 due to a risk of internal wires becoming exposed, which could cause complications during procedures. This recall affects medical devices used in heart and blood vessel treatments.
The catheter's primary segment material can become exposed, revealing stainless-steel braid wires. This could lead to complications like kinks or blockages during procedures, potentially causing injury to blood vessels.
Healthcare professionals using the specific catheter model for cardiovascular procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used improperly.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F HSIII SH, .070", and reference number SA6HSIIISH. The product was sold with GTIN 00613994824141.
Identify the model, size, and reference number to confirm if your catheter is affected.
The recall indicates a potential risk, so affected catheters should not be used until the remedy is applied. The official notice does not specify a fix.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F HSIII SH, .070", and reference number SA6HSIIISH.
The recall does not provide a specific 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-2693-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2693-2019 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.