SHERPA NX ACTIVE SA6EBU45Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994824639), received between Aug 23, 2019 and Aug 23, 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 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-2633-2019 · 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.

• MalfunctionAug 23, 2019Peeled/Delaminated; Peeled/Delaminated

  A SHERPA GUIDE CATHETER WAS INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. IT WAS REPORTED THAT THE DISTAL OUTER LAYER WAS DETACHED FROM THE INNER LAYER. THE DEVICE WAS NOT USED IN THE PATIENT. AT THE FACILITY DEVICES ARE STORED IN A CLOSET IN THE BOXES AWAY FROM ANY LIGHT SOURCE. WHEN DEVICES ARE RECEIVED AT THE ACCOUNT THEY ARE STORED IN THE WAREHOUSE. DEVICES ARE NOT WIPED AT ANY STAGE AT THE ACCOUNT. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN THE PATIENT HOWEVER THE DAMAGE OBSERVED INDICATES THAT AN ATTEMPT MAY HAVE BEEN MADE TO INSERT THE DEVICE INTO THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925432 ↗

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-2675-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. 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-2679-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
• Z-2625-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH. 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-2564-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
• Z-2639-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use
• Z-2659-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use
• Z-2748-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use
• Z-2663-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. for cardiovascular use
• Z-2660-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
• Z-2712-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. 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-2588-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
• Z-2641-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use

…and 175 more.