SHERPA NX BALANCED SB6IMAKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994827272), received between Jun 9, 2020 and Apr 11, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE CONTROL PROCEDURE ONE SHERPA GUIDE CATHETER WAS USED. ONE DAY LATER THE PATIENT SUFFERED FROM A HEMATOMA AT THE PROCEDURE ACCESS SITE. BLEEDING AROUND THE ACCESS SITE LED TO A HEMATOMA WHICH LED TO COMPRESSION OF THE FEMORAL VEIN. THE EVENT WAS TREATED WITH SURGICAL EVACUATION OF THE HEMATOMA AND MEDICATION. THE HEMATOMA WAS EVACUATED WHICH RESOLVED THE FEMORAL OBSTRUCTION. PATIENT RECOVERED WITHOUT SEQUELAE. THE CEC ADJUDICATED VASCULAR COMPLICATION, HEMATOMA AND COMMENTED HEMATOMA REQUIRING SURGICAL EVALUATION. CEC ADJUDICATED THE EVENT AS RELATED TO PROCEDURE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 16711535 ↗
• MalfunctionOct 21, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ONE SHERPA BALANCED GUIDE CATHETER WAS USED 5 DAYS PAST THE EXPIRATION DATE. NO PATIENT INJURY OR PROCEDURE ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10711460 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS IN CONTROL GROUP, ON MED. DURING THE CONTROL PROCEDURE ONE SHERPA GUIDE CATHETER WAS USED. APPROXIMATELY 7 MONTHS LATER THERE WAS SUSPICION OF DISSECTION OF THE LEFT RENAL ARTERY. NO ACTION TAKEN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND NOT RELATED TO THE THERAPY, STUDY CATHETER OR THE STUDY GENERATOR. SITE COMMENTED "POSSIBLE RELATION TO RENAL ANGIOGRAM AND DISSECTION UNLIKELY BUT CANNOT BE EXCLUDED". PATIENT RECOVERED WITHOUT SEQUELAE.

  Patient problems: Vascular Dissection

  MAUDE report 10132080 ↗

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-2588-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
• Z-2567-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. 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-2579-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use
• Z-2699-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. 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-2643-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. 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-2627-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
• Z-2582-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use
• Z-2601-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
• Z-2626-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
• Z-2681-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
• Z-2628-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. 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

…and 176 more.