Medtronic recalls certain SHERPA NX Active Guiding Catheters for possible wire exposure risk 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 specific SHERPA NX Active Guiding Catheters that may expose underlying steel wires, potentially causing injury during medical procedures. Patients using these catheters should contact Medtronic for details.
The catheter may lose its primary segment material, exposing stainless-steel braid wires. This could lead to complications during procedures like tissue damage or bleeding.
Medical professionals using the recalled catheters for cardiovascular procedures are most at risk. Patients who have received these catheters during procedures may need to contact Medtronic.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. on the product label or documentation. The recall covers all lot and serial numbers.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. on the product label or documentation.
The recall is due to a potential risk of extensive loss of primary segment material exposing underlying stainless-steel braid wires, which could cause complications during procedures.
Contact Medtronic directly for instructions on next steps, as the recall remedy is not specified in the record.
The recall states a potential risk of wire exposure, but the record does not specify if this can cause serious injury in normal use.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2640-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2640-2019 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.
