Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070" REF SA6MRADIAL for cardiovascular use due to potential loss of primary segment material exposing stainless-steel wires.
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 because it may expose underlying steel wires, which could cause serious injury if the catheter is used improperly. This recall affects catheters sold with the model number SA6MRADIAL and GTIN 00613994823052.
The catheter's outer layer may break off, exposing the inner steel wires. This could cause damage to blood vessels or tissue if the catheter moves unexpectedly during use.
Cardiovascular doctors and medical staff who use this catheter for procedures are most at risk. Patients receiving the catheter during procedures may also be affected.
Check for the model number SA6MRADIAL and GTIN 00613994823052 on the catheter packaging or label. The catheter is designed for cardiovascular procedures and sold with the specific size and reference.
Identify the model number SA6MRADIAL and GTIN 00613994823052 on the catheter packaging or label.
The recall states there is a potential risk of wire exposure, so it should not be used until the remedy is applied.
Look for the model number SA6MRADIAL and GTIN 00613994823052 on the catheter packaging or label.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2710-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2710-2019 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.