Medtronic recalls specific SHERPA NX catheters for potential wire exposure. Affected models include 6F RCB, .070" with REF SA6RCB. No remedy stated in official notice.
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. The recall is due to a risk of internal wires becoming exposed, which could cause complications during medical procedures.
The catheter's primary segment material may degrade, exposing the underlying stainless-steel braid wires. This could lead to complications during procedures such as kinking, blockages, or tissue damage.
Cardiovascular specialists and hospitals using the specific catheter model (6F RCB, .070", REF SA6RCB) are affected. Patients undergoing procedures with this catheter are at risk.
Check for the model: 6F RCB, .070" with reference number SA6RCB. The catheter is used for cardiovascular procedures and has a GTIN: 00613994822918.
Identify the model (6F RCB, .070"), reference number (SA6RCB), and GTIN (00613994822918) to confirm if your catheter is affected.
The recall states there is a potential risk of wire exposure, but no remedy is provided in the official notice.
The official notice does not specify any action steps for affected catheters.
Check the model (6F RCB, .070"), reference number (SA6RCB), and GTIN (00613994822918) to determine if it matches the recalled product.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2645-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2645-2019 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.
