Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F CHAMP3.0) due to potential exposure of stainless steel wires. Affected units may cause 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 certain SHERPA NX Active Guiding Catheters for cardiovascular use. The catheters could expose underlying stainless steel wires, which might cause injury during medical procedures.
The catheter's primary segment material could break off, exposing the stainless steel braid wires. This might cause injury during medical procedures if the wires become tangled or kinked.
Healthcare professionals using the catheters for procedures are most at risk. Patients receiving these catheters during medical treatments may also be affected.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30.' on the product. The recall covers all units with this specific model and lot/serial numbers.
Identify the model and lot/serial numbers to confirm if your catheter is affected.
The recall indicates a potential risk, so affected units should not be used until the remedy is applied.
Look for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30.' on the product label.
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-2749-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2749-2019 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.
