SHERPA NX ACTIVE SA63DRIGHTSHRecalls & 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-2649-2019 · 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-2573-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use
• Z-2702-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
• Z-2679-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
• Z-2604-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use
• Z-2631-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
• Z-2658-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0, .070", REF SA6JL50. for cardiovascular use
• Z-2614-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
• Z-2613-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use
• Z-2746-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use
• Z-2566-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. 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-2576-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. 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-2588-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
• Z-2628-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. for cardiovascular use

…and 175 more.