SHERPA NX ACTIVE SA6MPHKRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

190 other recalls cover devices cleared under the same FDA submission (K042489); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 15, 2019Terminated

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

   Z-2598-2019 · Root cause: Component design/selection · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042489. One submission often covers many models, so check the product and lot details in each record.

• Z-2648-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
• Z-2567-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
• Z-2668-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
• Z-2743-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
• Z-2722-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. for cardiovascular use
• Z-2719-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. for cardiovascular use
• Z-2751-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
• Z-2630-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
• Z-2597-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use
• Z-2644-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for cardiovascular use
• Z-2682-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
• Z-2596-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
• Z-2708-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
• Z-2733-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use
• Z-2752-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use

…and 175 more.