Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER models with potential for stainless steel wire exposure. Affected units may require replacement to prevent 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 due to a risk of stainless steel wires becoming exposed, which could cause injury during medical procedures. This recall affects catheters with the model number 6F MAC4.5, .070", REF SA6MAC45.
The catheter's primary segment material can become exposed, revealing stainless-steel braid wires. This could lead to injury if the wires cause damage during medical procedures.
Healthcare professionals using the catheter 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 number 6F MAC4.5, .070", REF SA6MAC45. on the catheter's packaging or label. The product was sold with GTIN 00613994822000.
Identify the model number 6F MAC4.5, .070", REF SA6MAC45. on the catheter or packaging.
Reach out to Medtronic Vascular for guidance on next steps if the catheter is affected.
The recall indicates a potential risk, so affected units should not be used until further instructions are received.
Check for the model number 6F MAC4.5, .070", REF SA6MAC45. on the catheter or packaging.
Contact Medtronic Vascular for specific instructions on how to handle the affected catheter.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2711-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2711-2019 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.
