Medtronic Vascular recalls SHERPA NX Active Guiding Catheters (6F AL2.0 SH) due to potential wire exposure. Affected units may have stainless steel wires exposed, risking injury during 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 for cardiovascular use. The catheters could expose underlying stainless steel wires, which might cause injury if the catheter is used improperly.
The catheter's primary segment material could break off, exposing the stainless steel braid wires. This might cause injury if the catheter is moved or manipulated during a procedure.
Healthcare professionals using the catheter for procedures are most at risk. Patients receiving the catheter during medical treatments may also be affected.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH' on the product. The recall covers all units with this specific model and lot/serial numbers.
Identify the model and lot/serial numbers on the catheter to confirm if it is affected.
Reach out to Medtronic Vascular for guidance on next steps if the catheter is recalled.
The recall indicates a potential risk, so affected units should not be used until further instructions are received.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH' and associated lot/serial numbers.
Contact Medtronic Vascular directly for specific instructions on handling the recalled product.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2625-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2625-2019 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.