Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters for possible exposure of stainless steel wires, posing a risk of injury during cardiovascular procedures.
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 exposing underlying stainless steel wires, which could lead to injury if the catheter is used improperly.
The catheter may lose its primary segment material, exposing the stainless steel braid wires. This could cause injury if the catheter is used incorrectly during a procedure.
Cardiovascular professionals who use the recalled catheters for procedures are most at risk. Patients undergoing procedures with these catheters may also be affected.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. The product was sold with a GTIN: 00613994823267 and specific lot/serial numbers.
Verify the model and serial numbers against the recall list provided by Medtronic Vascular.
The recall indicates a potential risk, 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.
Check for the model SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. with GTIN 00613994823267.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2605-2019 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.