Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070" REF SA6MRESS for cardiovascular use due to potential loss of primary segment material exposing stainless-steel wires.
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 Vascular is recalling a specific type of cardiovascular catheter because it may expose underlying steel wires, which could cause serious injury. This recall affects catheters with the model number SA6MRESS and is for medical use only.
The catheter's primary segment material may break off, exposing the stainless-steel braid wires. This could lead to complications like tissue damage or injury during procedures.
Healthcare professionals using this catheter for cardiovascular procedures are most at risk. Patients receiving the catheter during procedures may also be affected.
Check for the model number SA6MRESS on the catheter. The catheter has a size of 6F M RESS and a diameter of .070 inches. It was sold with the GTIN 00613994823045.
Identify the model number SA6MRESS and check the catheter's size (6F M RESS) and diameter (.070 inches).
The recall states there is a potential for wire exposure, so it is not safe to use without the remedy. However, the remedy is not specified in the record.
The recall record does not specify a remedy, so no action is required based on the information provided.
Look for the model number SA6MRESS, size 6F M RESS, diameter .070 inches, and GTIN 00613994823045.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-2636-2019 — Medtr: a short, human brand name for headings (e.g. "Trsmima") Medtr: a short, human brand name for Hello, I own a Medtr: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-2636-2019 from Medtr: a short, human brand name for headings (e.g. "Trsmima"). 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.
