SHERPA NX ACTIVE SA6RCBIIRecalls & 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-2706-2019 · 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-2685-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
• Z-2682-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
• Z-2582-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . 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-2725-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
• Z-2677-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for cardiovascular use
• Z-2577-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use
• Z-2574-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
• Z-2632-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use
• Z-2748-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. 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-2648-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
• Z-2593-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
• Z-2692-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
• Z-2688-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use

…and 175 more.