WavelinQ W04200Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00801741182754), received between Apr 25, 2019 and Jun 2, 2022 — classified as 9 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (31 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 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM', AFTER POST PROCEDURE THERE WERE TWO OCCURRENCES OF CARDIAC COMPLICATIONS. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14573078 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM', AFTER POST PROCEDURE THERE WAS ONE OCCURRENCE OF STEAL. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

  Patient problems: Ischemia

  MAUDE report 14573015 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM', AFTER POST PROCEDURE THERE WERE FIVE OCCURRENCES OF BLEEDING AND HEMATOMA. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14573014 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM, AFTER POST PROCEDURE THERE WERE FORTY THREE OCCURRENCES OF OCCLUSION OR STENOSIS. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 14573013 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL, APPROXIMATELY EIGHTEEN DAYS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE PATIENT HAD AN ADVERSE EVENT OF STENOSIS OF BASILIC, BRACHIAL AND PERFORATOR VESSEL. IT WAS FURTHER REPORTED THAT RE-INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ischemia; Numbness; Stenosis; Swelling/ Edema

  MAUDE report 13557943 ↗
• MalfunctionJun 2, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER ALLEGEDLY HAD ACTIVATION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919048 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL, POST DEVICE IMPLANTATION PERF/LATERAL RADIAL VEIN STENOSIS WAS REPORTED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 11918545 ↗
• MalfunctionApr 23, 2021Activation Failure; Activation Problem; Activation Failure; Activation Problem

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION PROCEDURE ON LEFT ARM, MEDIAL RADIAL VEIN AND RADIAL ARTERY, JUST DISTAL TO PERFORATOR VEIN, THE DEVICE ALLEGEDLY FAILED TO ACTIVATE IN ALL THREE ATTEMPTS. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715036 ↗
• MalfunctionMar 12, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE ARTERIOVENOUS FISTULA (AVF) CREATION PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO CUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468470 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY TITLED 'ISCHEMIC MONOMELIC NEUROPATHY AFTER PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION', APPROXIMATELY 6 DAYS POST PROCEDURE THE PATIENT DEVELOPED A SEVERE PAIN, ERYTHEMA IN THE FOREARM AND WAS DIAGNOSED WITH ISCHEMIC MONOMELIC NEUROPATHY (IMN). HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Erythema; Neuropathy; Pain

  MAUDE report 11395145 ↗
• MalfunctionFeb 9, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING CREATION OF LEFT ARM ULNAR FISTULA, THE CATHETER ALLEGEDLY FAILED TO CUT TISSUE, THEREFORE CONVERTED TO A SURGICAL FISTULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299801 ↗
• MalfunctionFeb 8, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO CUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11291452 ↗
• MalfunctionJan 25, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT AFTER THREE ATTEMPTS TO CREATE AN ULNAR-ULNAR FISTULA, THE VENOUS CATHETER ALLEGEDLY FAILED TO CREATE THE FISTULA AND THERE WAS ARM FLEXION DURING ACTIVATION. THEREFORE, THE CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221823 ↗
• MalfunctionOct 28, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION, THE MAGNETS WOULD NOT CONNECT. THEREFORE, THE CATHETERS WERE REMOVED, AND ANOTHER SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10745926 ↗
• MalfunctionOct 28, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION, THE MAGNETS WOULD NOT CONNECT. THEREFORE, THE CATHETERS WERE REMOVED, AND ANOTHER SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10745866 ↗
• MalfunctionSep 22, 2020Device-Device Incompatibility; Difficult to Advance; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA PROCEDURE THROUGH THE BRACHIAL VEIN, THE DEVICE ALLEGEDLY GOT STUCK WHILE ENTERING THE SHEATH AND INCREASED PRESSURE WAS APPLIED TO ADVANCE THE DEVICE FURTHER. IT WAS ALSO REPORTED THAT ELECTRODE WAS UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565817 ↗
• MalfunctionSep 18, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING THE ARTERIOVENOUS FISTULA PROCEDURE THE CATHETERS ALLEGEDLY FAILED TO ALIGN PROPERLY AND DID NOT HAVE PROPER COAPTATION. THEREFORE, A NEW SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10552309 ↗
• MalfunctionSep 18, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING THE ARTERIOVENOUS FISTULA PROCEDURE IN ULNAR VIA ANTI-PARALLEL BRACHIAL/ULNAR APPROACH, THE MAGNET ALLEGEDLY FAILED TO COAPT. THEREFORE, A NEW SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10552236 ↗
• MalfunctionAug 20, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) CREATION PROCEDURE, THE CATHETERS ALLEGEDLY FAILED TO ENERGIZED PROPERLY WHILE ATTEMPTING TO CREATE THE FISTULA. THE PROCEDURE WAS COMPLETED BY CREATING A SURGICAL FISTULA AND TWO UNSUCCESSFUL ATTEMPTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10430037 ↗
• MalfunctionAug 18, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE ELECTRODE ALLEGEDLY BROKE OFF IN THE YELLOW HEMOSTATIC VALVE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10418778 ↗
• MalfunctionAug 11, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ATTEMPT TO CREATE A ULNAR ARTERY - ULNAR VEIN ARTERIOVENOUS FISTULA, BOTH CATHETERS WERE ADVANCED INTO THE ULNAR VEIN AND ARTERY, AFTER THE CATHETERS WERE ALIGNED PERFECTLY, THE VENOUS CATHETER ALLEGEDLY FAILED TO CUT THE TISSUE. A SURGICAL FISTULA WILL BE SCHEDULED FOR A FUTURE DATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389430 ↗
• MalfunctionJul 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER THE VENOUS CATHETER WAS IN THE PATIENT, THE ELECTRODE WAS IDENTIFIED ALLEGEDLY BENT UNDER FLUOROSCOPY, PRIOR TO ACTIVATION/COAPTATION. THEREFORE, THE CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. REPORTEDLY, THE PROCEDURE WAS RESCHEDULED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243539 ↗
• MalfunctionJun 3, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ATTEMPT OF CREATION OF AN ARTERIOVENOUS FISTULA (AVF) THROUGH THE RADIAL ARTERY AND RADIAL VEIN FOR HEMODIALYSIS ACCESS, THE DEVICE ALLEGEDLY FAILED TO CUT THE TISSUE. THEREFORE, BOTH THE VENOUS AND ARTERIAL CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT AND A NEW SET OF CATHETERS WAS USED TO CREATE A SUCCESSFUL FISTULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113805 ↗
• MalfunctionApr 23, 2020Failure to Cut; Activation Problem; Failure to Cut; Activation Problem

  IT WAS REPORTED THAT DURING AN ACTIVATION ATTEMPT, THE VENOUS CATHETER ALLEGEDLY FAILED TO CUT THE TISSUE. THEREFORE, BOTH THE VENOUS AND ARTERIAL CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT AND A NEW SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9993130 ↗
• MalfunctionApr 23, 2020Failure to Cut; Activation Problem; Failure to Cut; Activation Problem

  IT WAS REPORTED THAT DURING AN ACTIVATION ATTEMPT, THE VENOUS CATHETER ALLEGEDLY FAILED TO CUT THE TISSUE. THEREFORE, BOTH THE VENOUS AND ARTERIAL CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT AND A NEW SET OF CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992769 ↗