Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F models due to potential loss of primary segment material exposing steel wires. Affected units have specific model and lot 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 a specific type of cardiovascular catheter because a small section of the catheter could break off, exposing metal wires inside. This could cause serious injury if the catheter moves during use.
The catheter's outer layer could break off, exposing the metal wires inside. If the catheter moves during use, the exposed wires might cause injury to blood vessels or tissue.
Cardiovascular patients who use this specific catheter model are most at risk. Healthcare providers who have the catheter in their inventory may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, length 55cm, and reference number SA6IMAK. The product was sold with specific lot/serial numbers.
Identify the model, size, and reference number to confirm if your catheter is affected.
The recall states there is a potential for the catheter to break off, exposing metal wires. This could cause injury if the catheter moves during use.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F, length 55cm, and reference number SA6IMAK. The product was sold with specific lot/serial numbers.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2562-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2562-2019 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.