SHERPA NX ACTIVE SA6MAC30Recalls & 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-2635-2019 · 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-2695-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
• Z-2745-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use
• Z-2704-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070", REF SA6JCL35. 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-2721-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. 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-2595-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use
• Z-2655-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. 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-2584-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use
• Z-2638-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0 SH, .070", REF SA6AL10SH. for cardiovascular use
• Z-2594-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
• Z-2714-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. 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-2623-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use

…and 175 more.