SHERPA NX ACTIVE SA6CHAMP35Recalls & 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 18, 2026.

Recalls naming this device

1. Mar 15, 2019Class ITerminated

   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-2743-2019 · 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-2707-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use
• Z-2697-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
• Z-2620-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use
• Z-2608-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
• Z-2587-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use
• Z-2738-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use
• Z-2685-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
• Z-2562-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
• Z-2643-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardiovascular use
• Z-2689-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascular use
• Z-2573-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use
• Z-2648-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
• Z-2739-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use
• Z-2678-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070", REF SA6AL40. for cardiovascular use
• Z-2683-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use

…and 175 more.