SHERPA NX ACTIVERecalls & reported problems across all models
Medtronic, Inc. · 190 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 191
We found 190 models of SHERPA NX ACTIVE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2017 and Aug 23, 2019 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (7 reports).
191 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
SHERPA NX ACTIVE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-2752-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2751-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2750-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2749-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2748-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2747-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2746-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2745-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2744-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2743-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2742-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2741-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2740-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2739-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2738-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2737-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2736-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2735-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2734-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2733-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2732-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2731-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2730-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2729-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2728-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2727-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2726-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2725-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2724-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
- 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-2723-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
…and 161 older recalls, listed on each model's page.
Most reported SHERPA NX ACTIVE problems
Device problems
- Peeled/Delaminated7
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
Patient problems
- No Consequences Or Impact To Patient5
- Device Embedded In Tissue or Plaque2
- Atrial Perforation1
- Hematoma1
SHERPA NX ACTIVE models
190 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- SHERPA NX ACTIVE SA6EBU375CATHETER, PERCUTANEOUS2 recalls0 reports
- SHERPA NX ACTIVE SA6IMAKCATHETER, PERCUTANEOUS1 recall5 reports
- SHERPA NX ACTIVE SA6JR40SHCATHETER, PERCUTANEOUS1 recall1 report
- SHERPA NX ACTIVE SA6EBU45CATHETER, PERCUTANEOUS1 recall1 report
- SHERPA NX ACTIVE SA6RDND1KCATHETER, PERCUTANEOUS1 recall1 report
- SHERPA NX ACTIVE SA6LCBSHDCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6LCBSHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6LCBDCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6LCBCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC3030CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC30SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6LARACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR60CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR50SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR50CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR45SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR45CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR40SHACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MP1SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MP1KCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MP1CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MB2SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MB2CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MB1SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MB1DCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MB1CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC50CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC45CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC40SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC375SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC375CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MAC35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL50CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL45SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL45CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL40SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL40DCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL40ACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL405CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL35ACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL355CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL30SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR40KCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR40DCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR40ACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR405CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR30SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JR30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL60SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL60CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL50SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6JL50ACATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MP2CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SL45CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SL40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SL35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SL30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SCR50CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SCR40SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SCR40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SCR35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SCR35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAR20CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAR10CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAL75SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SR40SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SR40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SR35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SR35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SR30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SL50CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAL75CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RCBIICATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RCBDCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RCBCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RBU45CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RBU40SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RBU40CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RBU35SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6RBU35CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6PK1WCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6NOTOSHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6NOTOCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MRESSCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MRADIALCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MPSTCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6MPHKCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAL30CATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAL20SHCATHETER, PERCUTANEOUS1 recall0 reports
- SHERPA NX ACTIVE SA6SAL20CATHETER, PERCUTANEOUS1 recall0 reports
Recent SHERPA NX ACTIVE adverse event reports
The 8 most recent reports across all models, 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 ↗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 ↗MalfunctionMay 23, 2019Peeled/Delaminated; Peeled/Delaminated
A SHERPA GUIDE CATHETER WAS USED. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING OR THE PROTECTIVE PACKAGING. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS LOSS OF THE DISTAL SEGMENT OUTER MATERIAL. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8636295 ↗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 ↗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 ↗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 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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