WavelinQ FX-001CERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00868260000211), received between Feb 27, 2019 and Nov 27, 2019 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ATTEMPT TO CREATE THE ARTERIOVENOUS FISTULA (AVF), THE VENOUS CATHETER ELECTRODE ALLEGEDLY FAILED TO CUT THE TISSUE ALTHOUGH IT WAS PROPERLY ALIGN WITH THE ARTERIAL CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9386189 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CREATION OF THE ARTERIOVENOUS FISTULA (AVF) IN THE ULNAR-ULNAR THROUGH BRACHIAL-BRACHIAL ACCESS, ALLEGED BLEEDING WAS IDENTIFIED AT THE ANASTOMOSIS GOING PAST THE VEIN AND INTO THE ARM. REPORTEDLY, STENTING WAS REQUIRED WITH A COVERED STENT TO SHUT DOWN THE FISTULA/BLEEDING, AND A SURGICAL GRAFT WILL BE CREATED AT A LATER DATE. THE PATIENT DID NOT HAVE ANY ISSUES POST STENTING PROCEDURE, AND ADEQUATE DISTAL FLOW WAS CONFIRMED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Injury

  MAUDE report 9380138 ↗
• MalfunctionNov 26, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ATTEMPT TO CREATE THE ARTERIOVENOUS FISTULA (AVF), THE VENOUS CATHETER ELECTRODE ALLEGEDLY FAILED TO CUT THE TISSUE ALTHOUGH IT WAS PROPERLY ALIGN WITH THE ARTERIAL CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379399 ↗
• InjuryAug 8, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ARTERIOVENOUS FISTULA (AVF) ALLEGEDLY FAILED TO CREATE IN THE RIGHT ARM, THEREFORE, A SURGICAL FISTULA WAS REQUIRED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Fistula

  MAUDE report 8876619 ↗
• MalfunctionJun 19, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE ARTERIOVENOUS FISTULA (AVF) CREATION PROCEDURE THROUGH THE LEFT MEDIAL BRACHIAL VEIN AND LEFT BRACHIAL ARTERY ACCESS, THE ELECTRODE ALLEGEDLY WAS UNABLE TO CUT THE TISSUE. THEREFORE, THE CATHETERS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT, AND A NEW CATHETER SET WAS USED TO CREATE THE PATIENT'S FISTULA IN THE LEFT MEDIAL ULNAR VEIN AND LEFT COMMON ULNAR ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713001 ↗
• MalfunctionApr 30, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT AFTER THE DEVICES WERE SUCCESSFULLY INSERTED AND NAVIGATED TO THE TARGET LESION, THE DEVICES ALLEGEDLY FAILED TO ALIGN PROPERLY. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER MADE THE DECISION TO ATTEMPT TO CREATE THE FISTULA, HOWEVER, NO FISTULA WAS CREATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567555 ↗
• MalfunctionApr 29, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT UPON ACTIVATION OF THE DEVICES IN THE ULNAR ARTERY AND VEIN, THE ELECTRODE ALLEGEDLY FAILED TO CUT THE TISSUE. REPORTEDLY, NO FISTULA WAS FORMED, AND NO FURTHER ATTEMPTS WERE MADE TO CREATE THE ARTERIOVENOUS FISTULA (AVF). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8563136 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SUCCESSFULLY CREATING AN ARTERIOVENOUS FISTULA (AVF) IN THE ULNAR ARTERY AND VEIN, THE FISTULA WAS IDENTIFIED CLOSED DURING THE 0-10 DAY FOLLOW UP, AND AN ALLEGED PSEUDOANEURYSM WAS ALSO OBSERVED. REPORTEDLY, THE PSEUDOANEURYSM RESOLVED WITHOUT REQUIRING ANY TREATMENT.

  Patient problems: Injury

  MAUDE report 8563095 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST SUCCESSFUL FISTULA CREATION, THE PATIENT DEVELOPED AN ALLEGED ANEURYSM BETWEEN THE ULNAR ARTERY AND ULNAR VEIN REQUIRING THE PATIENT TO GO INTO SURGERY FOR A BYPASS PROCEDURE. IT WAS FURTHER ALLEGED THAT THERE WAS SOME EXTRAVASATION AND SPASMS AFTER THE SUCCESSFUL FISTULA CREATION PROCEDURE BUT, NO TREATMENT WAS PROVIDED. REPORTEDLY, THE PATIENT IS DOING WELL POST BYPASS SURGERY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8501970 ↗
• MalfunctionFeb 27, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING CREATION OF A FISTULA IN THE BRACHIAL VEIN AND BRACHIAL ARTERY THROUGH THE ULNAR VEIN AND ARTERY, THE DEVICE FAILED TO CREATE A FISTULA AS IT WAS ALLEGEDLY UNABLE TO CUT ALL THE WAY THROUGH THE ARTERY TISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376461 ↗