Medtronic recalls specific 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 certain SHERPA NX Active Guiding Catheters used in heart procedures. The catheters may expose underlying steel wires, potentially causing injury during use.
The catheter's outer layer may break, exposing thin steel wires. These wires could cause injury if they contact tissue during a procedure.
Cardiovascular doctors and medical staff who use these catheters for procedures. Patients undergoing heart-related surgeries are at risk if the catheter is used.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. The product was sold for cardiovascular use with GTIN 00613994823601.
Identify if your catheter matches the model and reference number described in the recall.
The recall states there is a potential risk of wire exposure, so it is not recommended for use until the recall is addressed.
Look for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. with GTIN 00613994823601.
The recall does not specify a remedy, so contact Medtronic for guidance on next steps.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2666-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2666-2019 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.
