Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure during cardiovascular procedures. Affected units have a risk of stainless steel wires becoming exposed, potentially causing injury. Contact Medtronic for details.
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 stainless steel wires exposed. This could lead to injury during procedures if the catheter is used improperly.
The catheter's primary segment material may break off, exposing the underlying stainless steel braid wires. This could cause injury if the wires become tangled or kinked during procedures.
Healthcare professionals who use these catheters for cardiovascular procedures are most at risk. Patients undergoing procedures with the recalled catheters could also be affected.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH' on the product. The recall covers all units with this specific model and lot/serial numbers.
Identify the model and lot/serial numbers to confirm if your catheter is affected.
The recall indicates a potential risk, so affected units should not be used until contacted by Medtronic.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH' and the lot/serial numbers listed in the recall.
Contact Medtronic directly for instructions on how to handle the affected unit.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2661-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2661-2019 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.