Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F MAC4.0 SH) due to potential loss of primary segment material exposing stainless-steel wires. Affected units have specific model and serial numbers.
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 certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures. The catheters may have a risk of losing their outer layer, exposing internal steel wires that could cause injury during use.
The catheter's outer layer may break off during use, exposing the internal steel wires. This could cause injury to the patient's blood vessels or tissue if the wires move unexpectedly.
Healthcare professionals who use these catheters for procedures are most at risk. Patients receiving these catheters during treatment may also be affected.
Check for the model number 6F MAC4.0 SH, size .070", and reference SA6MAC40SH. The product was sold with specific lot and serial numbers.
Identify the model number, size, and reference number on the catheter packaging or label.
The recall states there is a potential risk of wire exposure, so users should check if their catheter is affected before use.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model number 6F MAC4.0 SH, size .070", and reference SA6MAC40SH on the catheter or packaging.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2729-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2729-2019 from Medtr: 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.
