Medtronic recalls specific SHERPA NX catheters for possible 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, potentially causing injury if used improperly.
The catheter's primary segment material could wear away, exposing thin stainless-steel wires. If these wires become tangled or kinked during procedures, they might cause injury to blood vessels or tissue.
Cardiovascular professionals using the specific catheter model are most at risk. Patients receiving procedures with these catheters may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F LARA, diameter .070", and reference number SA6LARA. The product was sold with GTIN 00613994821775.
Identify the model, size, and reference number 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.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F LARA, diameter .070", and reference number SA6LARA.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2688-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2688-2019 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.