Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F, IMA SH, 60cm) 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 certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures because a subset may have primary segment material that could wear away, exposing steel wires. This could lead to complications during medical procedures if the catheter is used.
The catheter's primary segment material may wear away over time, exposing the underlying stainless-steel braid wires. This could cause the wires to become tangled or kinked during procedures, potentially leading to complications like blockages or injuries.
Cardiovascular doctors and medical staff who use these catheters during procedures are most at risk. Patients receiving these catheters are also affected but typically under medical supervision.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070"' with reference number SA6IMASHJ. The product was sold with specific lot and serial numbers.
Verify the model and reference number on the catheter packaging or label to confirm if it is affected.
The recall states that a subset of these catheters may have a risk of exposing steel wires, so they should not be used until the recall is addressed.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070"' with reference number SA6IMASHJ on the packaging or label.
The recall does not specify a remedy, so contact Medtronic Vascular directly to determine next steps.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2586-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2586-2019 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.
