Medtronic recalls specific SHERPA NX Active Guiding Catheters for possible wire exposure risk during cardiovascular procedures. Affected units include 6F MB2, .070" model with REF SA6MB2.
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 could cause serious complications during medical procedures if the catheter is used improperly.
The catheter's primary segment material could become exposed, revealing stainless-steel braid wires. This might cause unintended tissue damage or complications during procedures if the catheter is not handled correctly.
Healthcare professionals using the catheter for cardiovascular procedures are most at risk. Patients receiving these procedures may be affected if the catheter is used without proper checks.
Check for the model 6F MB2, .070" with reference number SA6MB2. The catheter is used for cardiovascular procedures and has a GTIN: 00613994821928.
Verify the model number, size, and reference number on the catheter packaging or label.
Reach out to Medtronic Vascular directly for assistance with the recall process.
The recall indicates a potential risk, but the catheter is generally safe. Affected units should be checked for the specific model and reference number.
Contact Medtronic Vascular directly to determine if your specific catheter is affected and what steps to take.
Check for the model 6F MB2, .070" with reference number SA6MB2. The catheter is used for cardiovascular procedures and has a GTIN: 00613994821928.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2653-2019 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-2653-2019 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.