CLASS I Device recall · Reported 9 Oct 2019 · FDA Enforcement Report

Sherpa Nx Active Guiding Catheter, 6f Ebu3.5, .070" recalled

Medtronic Vascular is recalling Sherpa Nx Active Guiding Catheter, 6f Ebu3.5, .070". The recall was initiated on 15 Mar 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN: 00613994823625 All Lot/Serial Numbers

Quantity recalled2607 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2622-2019
FDA event ID: 82525
Recalling firm: Medtronic Vascular, Danvers, MA
Classification: Class I
Status: Completed
Recall initiated: 15 Mar 2019
FDA classified: 30 Sep 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Mar 2019	Recall initiated by company
30 Sep 2019	Classified by FDA	+199 days
9 Oct 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Product as listed by the FDA

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. for cardiovascular use

Where it was distributed

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

Questions about this recall

Why was it recalled?

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Which lots are affected?

GTIN: 00613994823625 All Lot/Serial Numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 82525

This product is part of a recall event; the main page for the event is Sherpa Nx Active Guiding Catheter, 6f Al1.0, .070" recalled.

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al1.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl3.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, 3drc .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Erad Right Short Tip, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sl4.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al2.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Lcb, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al20 recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sl5.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ2.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al.75, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ebu4.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Lara, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sl4.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Rdnd1 .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ1.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sal.75, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ebu3.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Champ2.0070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al3.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sr3.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Rbu4.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Scr3.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mac5.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ebu4.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Erad Left, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Alr1-2 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sal1.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f El Gamal Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f M Radial, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Pk1, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mac4.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl4.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Champ0.5070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Rcb, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ecr4.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Mb1, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ2.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ3.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Erad Left, Long Tip, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ebu4.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mp1, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Hsiii Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa NX Active Guiding Catheter, 6F MAC3.0 30o, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ebu3.5070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al1.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ima Sh, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Al3.0070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jr6.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mac 3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sr3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl4.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sl3.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jr6.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ecr3.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Lcb Sh, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mp2, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mac4.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Ebu3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f 3dright Sh .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Jl3.5, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sar2.0 .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al1.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Rrad, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Sr4.0 Sh, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Scr5.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Fr3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ1.5 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ima .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jcl3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Hsiii, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Champ1.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Champ0.5 Sh070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Erad Right, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Jcr4.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sal1.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Mp1, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Jl4.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jr3.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Mac3.0 .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Sr4.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Jl4.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f 3drc recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Jl5.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Fl4.0070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ebu3.5070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Rbu4.0, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al1.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ebu4.0070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Scr3.5, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Rcbii, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Jl5.0 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Sal.75 Sh, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Sr3.0, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Lcb, .070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f, Ima Sh, 070" recalled	Medtronic Vascular	Other	MA
9 Oct 2019	CLASS I	Sherpa Nx Active Guiding Catheter, 6f Al3.0 Sh, .070" recalled	Medtronic Vascular	Other	MA

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