SHERPA NX ACTIVE SA6SAL10SHRecalls & 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-2705-2019 · 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-2563-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
• Z-2667-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. for cardiovascular use
• Z-2661-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
• Z-2725-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
• Z-2586-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
• Z-2656-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
• Z-2707-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use
• Z-2599-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
• Z-2575-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
• Z-2647-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for cardiovascular use
• Z-2686-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use
• Z-2601-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
• Z-2619-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
• Z-2694-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use
• Z-2687-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use

…and 175 more.