Medtronic recalls specific SHERPA NX Active Guiding Catheters for potential loss of primary segment material exposing stainless steel wires. Affected units may require replacement to prevent injury during cardiovascular 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 because a subset may have primary segment material that could be lost, exposing underlying steel wires. This could lead to complications during medical procedures if the catheter is used.
The catheter's primary segment material may become exposed, revealing stainless steel braid wires. This could cause complications during procedures like kinking, blockages, or damage to blood vessels.
Healthcare professionals who use these catheters for cardiovascular procedures are most at risk. Patients undergoing procedures with these catheters could be affected if the device is used.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. The product was sold with GTIN 00613994823540 and all lot/serial numbers.
Verify the model number SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. on the device or packaging.
The recall states that a subset of these catheters may have a risk of primary segment material loss exposing steel wires, so they should not be used without checking the recall details.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. with GTIN 00613994823540 and all lot/serial numbers.
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-2615-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2615-2019 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.
