Symplicity Spyral™ RDN016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000354466), received between Jul 17, 2024 and Apr 29, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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

• MalfunctionApr 29, 2026Entrapment of Device; Difficult to Insert; Material Deformation; Material Split, Cut or Torn

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE SYMPLICITY SPYRAL CATHETER WHEN ENTRAPMENT OCCURRED AND THE CATHETER WAS NOTED TO BE FRAYED. THE SPYRAL CATHETER WAS USED FOR 6 ABLATIONS/TREATMENTS ON A NON-MEDTRONIC 0.014 GUIDEWIRE WITH NO ISSUES. AS THE GUIDEWIRE WAS BEING PULLED BACK INTO THE SPYRAL CATHETER, RESISTANCE WAS NOTED. A FEW TECHNIQUES WERE TRIED BUT THE RESISTANCE WAS STILL OBSERVED. AFTER WITHDRAWING THE GUIDEWIRE AND SPYRAL CATHETER FROM THE PATIENT, IT WAS NOTED THE CATHETER APPEARED FRAYED AND HUNG UP ON THE GUIDEWIRE. A NEW GUIDEWIRE AND A NEW SPYRAL CATHETER WERE USED TO COMPLETE THE ABLATIONS. BOTH RENAL ARTERIES WERE BEING TREATED. THE RENAL ARTERY HAD A SMALL AMOUNT OF TORTUOSITY PRESENT. THE ILIAC ARTERY HAD NO TORTUOSITY PRESENT AND A LITTLE CALCIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027928 ↗
• InjuryNov 21, 2025Failure to Cycle; High Readings; Positioning Problem; Failure to Cycle; High Readings; Positioning Problem

  IT WAS REPORTED THAT DURING A RENAL DENERVATION PROCEDURE INVOLVING ONE SYMPLICITY SPYRAL CATHETER AND ONE SYMPLICITY G3 GENERATOR, THE PATIENT'S HEART RATE DROPPED BELOW TWENTY BEATS PER MINUTES (BPM). THE PATIENT DID NOT HAVE A HISTORY OF BRADYCARDIA. THE VESSEL BEING TREATED WAS THE LEFT RENAL ARTERY WHICH WAS SEVERELY TORTUOUS AND NON-CALCIFIED. THE PATIENT WAS TREATED MORE PROXIMALLY IN TORTUOUS ANATOMY. THE ISSUE WAS ENCOUNTERED WHEN THREE ABLATIONS WERE ATTEMPTED. THE CYCLES WERE THEN INTENTIONALLY STOPPED WITHIN THIRTY SECONDS. THE PATIENT'S HEART RATE RETURNED TO NORMAL IMMEDIATELY AFTER HALTING ABLATIONS AND ADMINISTERING ATROPINE. HIGH IMPEDANCE AND/OR HIGH TEMPERATURE RISE MESSAGES WERE DISPLAYED ON THE GENERATOR AND SOME ELECTRODES SHUT DOWN. POSITIONING/ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. IT WAS DETERMINED THAT THE PROXIMAL SEGMENT OF THE LEFT RENAL ARTERY WAS 8-9MM PROXIMALLY AFTER GIVING NITROGLYCERIN PER STANDARD OPERATING PROCEDURE AND PERFORMING INTRAVASCULAR ULTRASOUND IMAGING (IVUS). IT WAS BELIEVED THAT THE SPYRAL CATHETER FUNCTIONED PROPERLY AND THAT THE ISSUE WAS RATHER THAT THE INADEQUATE SEDATION WAS CAUSING THE PATIENT TO BEAR DOWN. IT WAS SUBSEQUE

  Patient problems: Bradycardia

  MAUDE report 23615089 ↗
• InjuryMay 15, 2025Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SYMPLICITY SPYRAL CATHETER, THE DEVICE FAILED TO ADVANCE/POSITION AND THE TIP OF THE CATHETER BROKE OFF. BOTH RENAL ARTERIES WERE BEING TREATED, WHICH HAD LITTLE TORTUOSITY AND LITTLE CALCIFICATION WITH 0% STENOSIS. THE ILIAC ARTERY ALSO HAD LITTLE TORTUOSITY. THE SPYRAL CATHETER WAS DAMAGED AS IT WAS ADVANCED THROUGH THE PROXIMAL LEFT RENAL. THERE WAS A STENT PRESENT THAT WAS PLACED APPROXIMATELY FOUR MONTHS PREVIOUSLY IN THE PROXIMAL RENAL ARTERY AND RESISTANCE WAS FELT WHEN ADVANCING THROUGH THE STENT. THE CATHETER BECAME STUCK UNDER A STENT STRUT. WHEN THE CATHETER WAS REMOVED, THE TIP OF THE CATHETER AND DISTAL ELECTRODE BECAME DETACHED. THE SPYRAL CATHETER AND A 6F LAUNCHER GUIDE CATHETER GUIDE WERE REMOVED. IMAGING REVEALED THAT THE ELECTRODE HAD MIGRATED TO THE RIGHT PROFUNDA. THE LEFT RENAL ARTERY WAS RE-ENGAGED, AND A NON-MEDTRONIC GUIDEWIRE WAS USED TO ACCESS THE MIDDLE DISTAL BRANCH. A TELESCOPE GUIDE EXTENSION CATHETER WAS ADVANCED DISTAL TO THE RENAL STENT. A NEW SYMPLICITY SPYRAL CATHETER WAS THEN SUCCESSFULLY ADVANCED INTO THE DISTAL BRANCH, AND RENAL DENERVATION (RDN) WAS PERFORMED ON TWO BRANCHES AND THE MAIN A

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 22026600 ↗
• 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 20831268 ↗
• MalfunctionJul 17, 2024Entrapment of Device; Difficult to Insert; Material Deformation; Entrapment of Device; Difficult to Insert; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE SYMPLICITY SPYRAL CATHETER DURING A RENAL DENERVATION PROCEDURE. DURING THE PROCEDURE ONE LAUNCHER GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE ALSO USED. IT WAS REPORTED THAT THE SPYRAL CATHETER BECAME STUCK IN THE NON MEDTRONIC TUOHY. IT WAS DETAILED THAT THE SPYRAL CATHETER WAS UNABLE TO ADVANCE DUE TO BEING CAUGHT IN THE NON MEDTRONIC TUOHY AND IT HAD TO BE REMOVED. THE ISSUE OCCURRED DURING FIRST INSERTION INTO PATIENT AND THE SPYRAL CATHETER HAD BEEN USED TO PERFORM ABLATIONS/TREATMENTS PRIOR TO BEING GETTING CAUGHT IN THE TUOHY. IT WAS NOT POSSIBLE TO GET THE SPYRAL CATHETER UNTANGLED FROM THE TUOHY WHILE STILL INSIDE THE PATIENT AND WAS UNABLE TO PRESERVE THE SPYRAL CATHETER TO CONTINUE ABLATING WITH THAT SPECIFIC CATHETER. THE OPERATOR FELT THAT THE BEST DECISION TO ENSURE PATIENT SAFETY WAS TO REMOVE SPYRAL CATHETER FROM THE PATIENT¿S BODY. AFTER BOTH THE TUOHY AND THESPYRAL CATHETER WERE REMOVED FROM THE PATIENT, THE SPYRAL CATHETER COULD BE REMOVED FROM THE TUOHY. THERE WAS DAMAGE NOTED TO THE SPYRAL CATHETER WHILE REMOVING FROM THE TUOHY. THE WAS NO MEDICAL OCCURRENCE, DISEASE OR INJURY REPORTED. THE SPYRAL CATHETER AND TUOHY WERE REPLAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759915 ↗