Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters due to potential metal wire exposure. Affected models include 6F, SR4.0 SH, 100CM, 070" with serial number SA6SR40SH. No remedy is stated in the recall notice.
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 that could expose metal wires, potentially causing injury. This recall affects catheters with the model number SA6SR40SH. The hazard is not described as life-threatening but requires attention to prevent injury.
The catheter's primary segment material could break off, exposing the underlying stainless-steel braid wires. This may cause injury to the patient during medical procedures if the exposed wires become tangled or cause damage.
Cardiovascular doctors and medical professionals who use the SHERPA NX Active Guiding Catheter for procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check for the model number SA6SR40SH on the catheter's packaging or label. The catheter is designed for cardiovascular use and has a specific length (100cm) and size (070").
Look for the model number SA6SR40SH on the catheter's packaging or label.
The recall notice does not state any remedy or fix for this issue.
Check for the model number SA6SR40SH on the catheter's packaging or label.
The recall notice does not specify any action steps for affected catheters.
We’ve drafted a message you can send Medtr: a short, human brand name for headings (e.g. "Trsmima") to request your refund or repair — edit it as you like.
Subject: Recall Z-2609-2019 — Medtr: a short, human brand name for headings (e.g. "Trsmima") Medtr: a short, human brand name for Hello, I own a Medtr: a short, human brand name for headings (e.g. "Trsmima") that is covered by recall Z-2609-2019 from Medtr: a short, human brand name for headings (e.g. "Trsmima"). 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.