SHERPA NX ACTIVE SA6RDND1KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169013520), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

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-2563-2019 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Peeled/Delaminated; Peeled/Delaminated

  A SA6RDND1K SHERPA CATHETER WAS INTENDED TO BE USED DURING A RENAL DENERVATION PROCEDURE. THE SHERPA CATHETER WAS USED FOR BOTH LEFT AND RIGHT RENAL ARTERY. NO DAMAGE NOTED TO PACKAGING. DEVICE WAS REMOVED FROM PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES AND PREPPED WITH NO ISSUES AS PER IFU. THERE WERE NO ISSUES NOTED WHEN INSERTING THE SHERPA DEVICE. A 6F NON-MDT INTRODUCER WAS USED. A NON-MDT GUIDEWIRE AND A SYMPLICITY SPYRAL RDN CATHETER WAS ALSO USED. IT IS REPORTED THAT DEVICE DAMAGE OCCURRED. THE OUTER LAYER SEPARATED FROM THE INNER LAYER AT THE END OF THE PROCEDURE WHEN THE DEVICE WAS EXITING THE INTRODUCER. THE OUTSIDE OF THE GUIDE CATHETER WAS NOT WIPED AT ANY STAGE AND THE DEVICE WAS NOT RE-STERILIZED. ASPIRATION WAS NOT PERFORMED IN THE PROCEDURE. IT IS INDICATED THAT THERE ARE NO DEVICE FRAGMENTS REMAINING IN THE PATIENT, ALL THE PIECES SEEMED TO BE WITHIN THE INTRODUCER. IT IS STATED THAT THE DEVICE WAS INSIDE THE PATIENT FOR APPROXIMATELY 30 - 40 MINS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8447638 ↗

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-2708-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
• Z-2654-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. 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-2734-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
• Z-2616-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use
• Z-2737-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
• Z-2635-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070", REF SA6MAC30. for cardiovascular use
• Z-2633-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. 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-2701-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. 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-2598-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use
• Z-2657-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. for cardiovascular use
• Z-2589-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
• Z-2709-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use

…and 175 more.