SHERPA NX ACTIVE SA6FR40Recalls & 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-2716-2019 · 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-2570-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use
• Z-2568-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
• Z-2578-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
• Z-2665-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use
• Z-2572-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use
• Z-2691-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
• Z-2744-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
• Z-2728-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
• Z-2731-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use
• Z-2640-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. 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-2674-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. for cardiovascular use
• Z-2576-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
• Z-2571-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
• Z-2684-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use

…and 175 more.