Medtronic recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure risk during cardiovascular procedures. Affected models include 6F JR4.0 SH, .070" with reference SA6JR40SH.
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 because a subset may have exposed stainless-steel wires. This could cause serious complications if the catheter is used improperly.
The catheter's primary segment material may degrade, exposing underlying stainless-steel braid wires. This could lead to complications like kinking or blockages during procedures if the catheter is used without proper handling.
Cardiovascular professionals who use the recalled catheters are most at risk. Patients undergoing procedures with these catheters may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR4.0 SH, .070", and reference number SA6JR40SH. The product was sold with GTIN 00613994821850.
Verify the model, size, and reference number to confirm if your catheter is affected.
The recall is due to a potential risk of extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of these catheters.
The recall record does not specify a remedy, so contact Medtronic Vascular directly for guidance.
The hazard description mentions potential wire exposure, which could lead to complications during procedures, but the recall does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2628-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2628-2019 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.
