Medtronic recalls SHERPA NX Active Guiding Catheters (6F HSIII) due to potential exposure of stainless steel wires. Affected units have specific model and lot numbers. Contact for replacement.
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 small section of the catheter could expose underlying steel wires. This poses a risk of serious injury during medical procedures.
The catheter's primary segment material could break off, exposing the stainless steel braid wires inside. This might cause injury to the patient or damage to medical equipment during procedures.
Cardiovascular doctors and medical staff who use the recalled catheters during procedures are most at risk. Patients receiving these catheters are not directly affected by the recall.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII' with the GTIN 00613994824158. All lot and serial numbers are included in the recall.
Identify the model number and lot/serial numbers to confirm if your catheter is affected.
Reach out to Medtronic Vascular for instructions on replacement or repair.
The recall states that a subset of these catheters has a potential risk, so they should not be used until the manufacturer provides a remedy.
Check for the model 'SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII' with the GTIN 00613994824158 and all lot/serial numbers.
Contact Medtronic Vascular directly for instructions on replacement or repair.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2702-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2702-2019 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.