SHERPA NX ACTIVE SA6JR45SHRecalls & 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-2752-2019 · 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-2729-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
• Z-2693-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for cardiovascular use
• Z-2610-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
• Z-2680-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiovascular use
• Z-2652-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardiovascular use
• Z-2688-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use
• Z-2689-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. 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-2676-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular use
• Z-2710-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use
• Z-2564-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
• Z-2705-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
• Z-2739-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use
• Z-2733-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use

…and 175 more.