CLASS I Device recall · Reported 9 Oct 2019 · FDA Enforcement Report
Sherpa Nx Active Guiding Catheter, 6f Scr3.5 Sh, .070" recalled
Medtronic Vascular is recalling Sherpa Nx Active Guiding Catheter, 6f Scr3.5 Sh, .070". The recall was initiated on 15 Mar 2019 and the FDA has classified it as Class I.
Check your package
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-2738-2019
- 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 SCR3.5 SH, .070", REF SA6SCR35SH. 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
Is Sherpa Nx Active Guiding Catheter, 6f Scr3.5 Sh, .070" recalled?
Yes. Medtronic Vascular recalled Sherpa Nx Active Guiding Catheter, 6f Scr3.5 Sh, .070" on 15 Mar 2019. The recall is Class I and its status is Completed. Recall number Z-2738-2019.
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: 00613994822604 All Lot/Serial Numbers
Where was it sold?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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