Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk during cardiovascular procedures. Affected units include 6F EBU4.0 models with serial number SA6EBU40.
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 because a subset may have exposed stainless-steel wires. This could cause serious complications if the catheter is used improperly.
The catheter's primary segment material may break off, exposing the underlying stainless-steel braid wires. This could cause damage to blood vessels or tissue during procedures if the wires move unexpectedly.
Cardiovascular doctors and medical staff who use these catheters during procedures are most at risk. Patients receiving these catheters are also affected but typically under medical supervision.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40.' The product was sold with a GTIN of 00613994823526 and all lot/serial numbers.
Identify the model and serial number to confirm if your catheter is affected.
The recall states that a subset of these catheters may have exposed wires, so they should not be used until the manufacturer confirms safety.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40.' with GTIN 00613994823526.
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-2621-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2621-2019 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.
