Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk 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 is recalling certain SHERPA NX Active Guiding Catheters used in heart procedures. The catheters may expose underlying steel wires, potentially causing serious complications if used improperly.
The catheter's primary segment material may break off during use, exposing the stainless-steel braid wires. This could cause tissue damage or blockages if the wires move unexpectedly during a procedure.
Cardiovascular doctors and medical staff who use these catheters for procedures are affected. Patients undergoing procedures with these catheters are at risk if the catheter malfunctions.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1' with GTIN 00613994821904. All lot and serial numbers are included in the recall.
Verify the model number and GTIN to confirm if your catheter is affected.
The recall states there is a potential risk, so it's recommended to check if your catheter is affected before use.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Look for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1' with GTIN 00613994821904.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2657-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2657-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.