Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk during cardiovascular procedures. Affected models include 6F 110CM AL20 with serial numbers starting with SA6AL20A.
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 small section of the catheter could break off, exposing metal wires inside. This could cause serious injury if the catheter moves during a procedure.
The catheter's outer layer could break off during use, exposing the internal metal wires. This might cause the catheter to move unexpectedly, potentially leading to injury or damage to blood vessels.
Healthcare professionals using the catheter for procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, length 110CM, and reference number SA6AL20A. The product was sold with a GTIN of 00613994823724.
Verify the model, size, length, and reference number to confirm if your catheter is affected.
The recall states there is a potential risk of wire exposure, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, length 110CM, and reference number SA6AL20A.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2611-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2611-2019 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.