SHERPA NX ACTIVE SA6IMAKRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994824059), received between Dec 7, 2017 and Aug 23, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 reports).

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-2562-2019 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  THE PHYSICIAN INTENDED TO USE A SHERPA GUIDE CATHETER. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER THE IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED AND THE DEVICE FAILED TO BE INSERTED INTO THE INTRODUCER SHEATH. IT IS REPORTED THAT WHEN THE CATHETER WAS EXTRACTED IT WAS NOTED THAT AT THE DISTAL PART OF THE CATHETER THE DOUBLE BRAID WAS NOT COVERED BY THE JACKET. NO PART OF THE CATHETER WAS INSERTED INTO THE INTRODUCER. THE TIP OF THE CATHETER WAS NOT ADVANCED BEYOND THE INTRODUCER TIP. NO EXCESSIVE FORCE WAS USED. THE EXPOSED BRAID WAS NOT NOTICED PRIOR TO INSERTION INTO THE INTRODUCER. THE INSPECTION WAS CARRIED OUT AFTER THE RESISTANCE WAS NOTED AND AFTER THE CATHETER HAD BEEN EXTRACTED. NO PATIENT INJURY IS REPORTED. THE ACCOUNT DID NOT SEE ANY OF THE BLUE SEGMENT MATERIAL ON THE DRAPE OR ENTRANCE OF THE INTRODUCER. WHEN THE EXPOSED BRAID WAS NOTED THE INTRODUCER WAS NOT SWITCHED. THE ISSUE WAS NOTICED BECAUSE THE CATHETER COULDN'T BE INSERTED INTO THE INTRODUCER SHEATH. THE CATHETER WAS NOT WIPED ON THE OUTSIDE WITH ANYTHING. THE CATHETER DID NOT COME INTO CONTACT WITH AN IMPLANTED DEVICE. THE CATHETER WAS NOT CLEANED PRIOR TO SHIPME

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925405 ↗
• MalfunctionApr 1, 2019Peeled/Delaminated; Peeled/Delaminated

  A SA6IMAK SHERPA GUIDE CATHETER WAS ATTEMPTED TO BE USED IN A RENAL DENERVATION PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS INSERTED THROUGH A 6F NON-MEDTRONIC INTRODUCER SHEATH OVER A 0.035" WIRE. THE PHYSICIAN STATED THAT IT FELT NORMAL AS IT WAS INSERTED THROUGH A SHEATH. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS ADVANCED THROUGH THE FEMORAL SHEATH TO THE AORTA. IT IS STATED THAT THE GUIDE CATHETER WAS NOT OFFERING SUPPORT. THE WIRE WAS PULLED BACK AND THE PHYSICIAN DIDN'T LIKE HOW THE GUIDE LOOKED SO IT WAS PULLED OUT TO BE INSPECTED. IT IS REPORTED THAT WHEN THE WIRE WAS PULLED BACK IT WAS NOTED THAT THE GUIDE TIP DID NOT HAVE ITS TYPICAL IMA UNSUPPORTED SHAPE AND IT WAS MOSTLY STRAIGHT IN LINE WITH SHAFT. THE GUIDE WAS REMOVED TO EXAMINE THE TIP AND IT WAS NOTED THAT THE OUTER COATING HAD BEEN REMOVED NEAR THE TIP OF THE GUIDE AND THE WIRE BRAIDING WAS EXPOSED. IT IS STATED THAT THE DEVICE WAS REMOVED SHORTLY AFTER INSERTION. AFT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8469242 ↗
• MalfunctionMar 25, 2019Peeled/Delaminated; Peeled/Delaminated

  A SA6IMAK SHERPA GUIDE CATHETER WAS INTENDED TO BE USED DURING A RENAL DENERVATION PROCEDURE IN THE OSTIUM OF THE RENAL ARTERIES, EXHIBITING NO CALCIFICATION AND NO STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM PACKAGING AS PER IFU. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. A 6F 25CM 2CM NON-MEDTRONIC SHEATH WAS USED. SLIGHT RESISTANCE WAS NOTED WHEN INSERTING THE SHERPA DEVICE. THE SHERPA WAS INSERTED OVER A GUIDE WIRE BUT NOT DEVICES WERE DELIVERED THROUGH THE SHERPA. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING THE DELIVERY. IT IS REPORTED THAT THE DEVICE WOULD NOT SEAT AT THE AORTA SO THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. WHEN REMOVED, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS EXPOSED AND THE BLUE SLEEVE COATING WAS MISSING. THE DEVICE DID NOT RETAIN ITS SHAPE. THIS OCCURRED AFTER THE FIRST ATTEMPT TO USE THE DEVICE. IT IS STATED THAT THE GUIDE CATHETER WAS INSIDE THE PATIENT FOR TWO MINUTES. THE OUTSIDE OF THE GUIDE CATHETER WAS NOT WIPED AT ANY STAGE. THE SHERPA DEVICE WAS NOT RE-STERILIZED. ASPIRATION WAS NOT PERFORMED IN THE PROCEDURE. NO FUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448402 ↗
• MalfunctionFeb 18, 2019Peeled/Delaminated; Device Damaged by Another Device; Peeled/Delaminated; Device Damaged by Another Device

  A SHERPA GUIDE CATHETER WAS INTENDED TO BE USED DURING A RENAL DENERVATION PROCEDURE TO TREAT A LESION IN THE OSTIUM RENAL ARTERY. A FEMORAL APPROACH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, AND NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING USE, WHILST INSERTING THE DEVICE THROUGH A 6F NON-MEDTRONIC INTRODUCER SHEATH. THE DEVICE WAS NOT EXCESSIVELY TORQUED. RESISTANCE WAS ALSO FELT WHEN MANEUVERING FOR ENGAGEMENT OF THE RENAL ARTERY. EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN REMOVED THE GUIDE CATHETER AFTER THE FIRST ATTEMPT AND NOTED THAT THERE WAS DAMAGE TO THE DISTAL PORTION OF THE DEVICE. IT WAS ALSO NOTED THAT THERE WAS DEBRIS OUTSIDE OF THE INTRODUCER SHEATH. THE DEVICE WAS ONLY ATTEMPTED TO BE USED ONCE. IT IS STATED THAT THE DEVICE WAS NOT RE-STERILIZED. ASPIRATION WAS NOT PERFORMED IN THE PROCEDURE. THE PHYSICAN EXCHANGED THE SHERPA DEVICE WITH A 5F NON-MEDTRONIC PIGTAIL CATHETER FOR AN AORTOGRAM. A 6F SA6RDND1K SHERPA GUIDE CATHETER WAS THEN INTRODUCED AND THE PHYSICIAN FELT RESISTANCE DURING INSERTION. AT THIS POINT THE PHYSICIAN D

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8347501 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX RENAL DENERVATION PROCEDURE THE LEFT RENAL ARTERY WAS TREATED FIRST. SIX ABLATIONS WERE PERFORMED. RIGHT RENAL ARTERY WAS TREATED SECOND. FOUR ABLATIONS WERE PERFORMED. IT WAS REPORTED THAT THERE WAS AN ARTERIAL PUNCTURE WITH USE OF THE CATHETER DURING THE INDEX PROCEDURE. THE PUNCTURE COULD BE SEEN ONLY AFTER THE PROCEDURE. TWO DAYS LATER THE PATIENT EXPERIENCED A MINOR HEMATOMA OF THE RIGHT GROIN. NO TREATMENT WAS GIVEN. INVESTIGATOR INDICATED THAT THE REPORTED HEMATOMA EVENT IS DEFINITELY RELATED TO THE RENAL DENERVATION DEVICE AND PROCEDURE. IT WAS CONFIRMED THAT THE HEMATOMA WAS THE RESULT OF AN UNINTENDED ARTERIAL PUNCTURE/PERFORATION. LOCATION OF THE PUNCTURED VESSEL WAS IN THE GROIN. NO TREATMENT WAS PROVIDED. THE HEMATOMA RESOLVED SPONTANEOUSLY.

  Patient problems: Atrial Perforation; Hematoma

  MAUDE report 7094850 ↗

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-2669-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use
• Z-2602-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use
• Z-2660-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. 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-2640-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. for cardiovascular use
• Z-2687-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use
• Z-2604-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. 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-2751-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. 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-2596-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
• Z-2632-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use
• Z-2668-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
• Z-2725-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
• Z-2720-2019 · Mar 15, 2019 · Terminated
  SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use

…and 175 more.