SHERPA NX BALANCED SB6RDND1KRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169093706), received between Oct 12, 2021 and Dec 3, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

191 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE RENAL ARTERIES. DURING THE PROCEDURE THE PATIENT SUFFERED FROM AN INFERIOR BRANCH SPASM. IT WAS STATED THAT INTRA-PROCEDURE THERE WAS SPASM IN THE INFERIOR BRANCH FOR WHICH NITROGLYCERIN WAS ADMINISTERED, RESOLVING THE SPASM. THE PATIENT RECOVERED. THE RATIONALE FOR THE RELATIONSHIP TO THE THERAPY, PROCEDURE AND SPYRAL CATHETER WAS THE SPASM WAS RELATED TO THE WIRE IN THE RENAL ARTERY SYSTEM. THERE IS NO REPORTED MALFUNCTION FOR THE SHERPA GUIDE CATHETER OR THUNDER GUIDEWIRE USED DURING THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20831259 ↗
• InjuryJan 6, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RENAL DENERVATION PROCEDURE (RDN), ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE RENAL ARTERIES. THE DEVICES WERE USED IN THE PROCEDURE APPROXIMATELY FIVE MONTHS PAST THEIR EXPIRATION DATE. ON THE SAME DAY POST RDN PROCEDURE, PATIENT SUFFERED PERFORATION IDENTIFIED POST TREATMENT IN THE RIGHT RENAL ARTERY. THE PROCEDURE WAS COMPLETED AND PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Perforation

  MAUDE report 13176246 ↗
• MalfunctionNov 12, 2021Use of Device Problem; Use of Device Problem

  A SHERPA GUIDE CATHETER WAS USED TO TREAT THE RIGHT AND LEFT RENAL ARTERIES. IT WAS REPORTED THAT THE DEVICE WAS USED OUTSIDE OF ITS EXPIRY DATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802451 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDE WIRE WERE USED TO TREAT THE LEFT AND RIGHT RENAL ARTERY. ON THE SAME DAY, DURING DENERVATION PROCEDURE, PATIENT SUFFERED FROM RENAL ATERIA DISSECTION WITH INFARCTION. THE EVENT WAS TREATED WITH MEDICATION AND THE PATIENT UNDERWENT A SURGICAL INTERVENTION. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 12613450 ↗

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-2702-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
• Z-2641-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
• Z-2685-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
• Z-2583-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use
• Z-2686-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. 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-2731-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use
• Z-2619-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
• Z-2717-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
• Z-2726-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5, .070", REF SA6ECR35. for cardiovascular use
• Z-2645-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use
• Z-2713-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070", REF SA6JR50SH. for cardiovascular use
• Z-2642-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5 SH, .070", REF SA6JL35SH. for cardiovascular use
• Z-2608-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
• Z-2673-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1 SH, .070", REF SA6MB1SH. for cardiovascular use

…and 176 more.