WavelinQ WQ4300Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00801741189104), received between Jan 6, 2020 and Sep 7, 2026 — classified as 6 deaths, 74 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (69 reports).

1 other recall cover devices cleared under the same FDA submission (K192239); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026Break; Device Dislodged or Dislocated; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50648893 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560477 ↗
• MalfunctionAug 19, 2026Failure to Align; Device Dislodged or Dislocated; Material Deformation

  On (b)(6) 2026, a patient underwent an endovascular arteriovenous fistula (AVF) creation procedure using a WavelinQ device via the medial radial vein and radial artery. During the procedure, the venous catheter failed to properly coapt with the arterial catheter. Upon removal of the venous catheter, the guidewire was observed to be dislodged from the catheter and kinked. As a result, the procedure was aborted, and the patient was scheduled for surgical arteriovenous fistula creation. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50320146 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (b)(6) THAT FIFTEEN DAYS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN TWO WEEKS OF INDEX PROCEDURE. IT WAS FURTHER REPORTED THAT SUBJECT UNDERWENT POST PROCEDURE INTERVENTION WITH INITIAL STENOSIS OF SIXTY NINE PERCENTAGE AND STENOSIS ON PERFORATOR VESSEL WITH INITIAL STENOSIS OF EIGHT NINE PERCENTAGE AND FINAL STENOSIS OF ZERO PERCENTAGE. ADDITIONALLY, IT WAS REPORTED THAT PATIENT HAD AN ADVERSE EVENT IN WHICH THE LEFT UPPER EXTREMITY WAS SWELLING WITH TIGHTNESS AND PAIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 25253428 ↗
• MalfunctionApr 22, 2026Break

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ENDOVASCULAR ARTERIOVENOUS FISTULA PROCEDURE USING THE WAVELINQ. IT WAS REPORTED THAT THE ELECTRODE BROKE BEFORE HE WAS ABLE TO ACTIVATE IT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951691 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT TWO WEEKS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN TWO WEEKS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. IT WAS FURTHER REPORTED THAT TWENTY-ONE DAYS LATER A SECOND STAGE PROCEDURE WAS PERFORMED TO SUPPORT MATURATION OF THE ARTERIALIZED VEIN SEGMENTS ON ULNAR ARTERY. APPROXIMATELY FOUR MONTHS AND TWENTY-FIVE DAYS LATER, A POST PROCEDURE INTERVENTION WAS PERFORMED ON CEPHALIC VEIN WITH INITIAL STENOSIS OF EIGHTY PERCENT AND FINAL STENOSIS OF TEN PERCENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 24882822 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (BPV18002) THAT ONE MONTH AND FIFTEEN DAYS LATER POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN SIX WEEKS OF ENDOAVF WAS NOT MATURED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 24739476 ↗
• InjuryMar 30, 2026Restricted Flow rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT NINE DAYS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN TWO WEEKS OF INDEX PROCEDURE, THE PATIENT UNDERWENT RECENT INTERVENTION FOR STENOSIS. IT WAS FURTHER REPORTED THAT CEPHALIC SIZE AND VOLUME FLOW NOT YET ADEQUATE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 24728975 ↗
• InjuryMar 30, 2026Restricted Flow rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT EIGHTEEN DAYS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN TWO WEEKS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 24727407 ↗
• MalfunctionMar 24, 2026Break; Failure to Cut

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION PROCEDURE USING THE WAVELINQ. DURING THE PROCEDURE THE CATHETER WAS INSERTED AND WAS HAVING TROUBLE FIRING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674378 ↗
• InjuryMar 18, 2026Restricted Flow rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (BPV18002) THAT TWO WEEKS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION BY USING THE WAVELINQ 4FR P. IT WAS REPORTED THAT THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN TWO WEEKS OF INDEX PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE SUBJECT UNDERWENT POST PROCEDURE INTERVENTION DUE TO ENDOAVF MATURITY INSUFFICIENCY AND ACCESS CIRCUIT STENOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 24628964 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (b)(4) THAT SIXTEEN DAYS POST AN ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN SIX MONTHS OF INDEX PROCEDURE. REPORTEDLY, ONE MONTH TWENTY SEVEN DAYS LATER, A SECOND STAGE PROCEDURE WAS PERFORMED TO SUPPORT MATURATION OF THE ARTERIALIZED VEIN SEGMENTS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE SUBJECT HAD ADVERSE EVENT OF STENOSIS WITH INITIAL PERCENTAGE OF SEVENTY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 24588068 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING SCREENING OF A PATIENT FOR ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, A NEW STENOSIS WAS IDENTIFIED AT THE DISTAL LOCATION OF THE RADIAL ARTERY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 24320345 ↗
• DeathJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY ((B)(4)) THAT APPROXIMATELY TWO MONTHS AND THIRTEEN DAYS AFTER AN INDEX PROCEDURE USING THE WAVELINQ ENDOAVF SYSTEM, THE PATIENT EVENTUALLY EXPIRED. THE RELATIONSHIP OF THE EVENT TO THE DEVICE, PROCEDURE, EMBOLIZATION DEVICE, CLOSURE DEVICE, AND THE AV ACCESS CIRCUIT WAS NOT REPORTED. FURTHERMORE, THE CAUSE OF DEATH WAS NOT DISCLOSED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190274 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT THREE MONTHS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24158906 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the results of a clinical trial (b)(6) that three months post-endovascular arteriovenous fistula creation using the Wavelinq 4FR P, the endovascular arteriovenous fistula was allegedly found to be not matured within three months of index procedure, by physical assessment. Reportedly, one month and twenty-four days later, a re-intervention procedure of standard PTA/BAM, Cutting/scoring balloons, and coiling/embolization on the Ulnar artery was performed for insufficient endoAVF Maturity, diversion of flow needed to target cannulation vessels and access circuit stenosis. Two months later it was further reported that the patient experienced left upper extremity swelling following a post-index procedure. Three months and one day post index procedure, an adverse event reported Left Forearm Swelling to upper arm swelling and the reintervention showed re-intervention reason was endoAVF Maturity Insufficient and Inadequate Arterial Flow. Four months and twenty-four days post index procedure, another adverse event was reported with Left arm Steal Syndrome. Reintervention was performed which reported, reason was Insufficient Blood Flow to the Hand (Steal Syndrome/Isch

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

  MAUDE report 24064725 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT SIX MONTHS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN SIX MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. REPORTEDLY, FIFTY-SIX DAYS AFTER THE STUDY PROCEDURE, A SECOND STAGE PROCEDURE WAS PERFORMED USING BALLOON ASSISTED MATURATION AND EMBOLIZATION COIL ON ULNAR ARTERY TO SUPPORT MATURATION OF THE ARTERIALIZED VEIN SEGMENTS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23895590 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ELEVEN DAYS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. IT WAS FURTHER REPORTED THAT POST-PROCEDURE INTERVENTION WAS PERFORMED DUE TO STENOSIS ON THE BRACHIOCEPHALIC VEIN AT THE PROXIMAL VESSEL WITH INITIAL STENOSIS OF 99% AND FINAL RESIDUAL STENOSIS OF 10%. REPORTEDLY, A SECOND STAGE PROCEDURE WAS PERFORMED TO SUPPORT MATURATION OF ARTERIALIZED VEIN SEGMENTS WITH EMBOLIZATION OF COIL WAS USED. THE PROCEDURE WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stenosis; Thrombosis/Thrombus

  MAUDE report 23786842 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY TWO WEEKS AFTER ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED. IT WAS FURTHER REPORTED THAT APPROXIMATELY FOUR WEEKS AFTER THE INDEX PROCEDURE, THE SUBJECT UNDERWENT A SECOND-STAGE PROCEDURE INVOLVING BALLOON-ASSISTED MATURATION AND COIL EMBOLIZATION TO SUPPORT CANNULATION OF THE ARTERIALIZED VEIN SEGMENTS. ADDITIONALLY, APPROXIMATELY ONE YEAR, ONE MONTH, AND THREE WEEKS AFTER THE ENDOVASCULAR FISTULA CREATION PROCEDURE, THE SUBJECT DEVELOPED CEPHALIC VEIN STENOSIS OF 43%. APPROXIMATELY THREE MONTHS LATER, THE SUBJECT UNDERWENT AN INTERVENTION ON THE ACCESS CIRCUIT USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A DRUG-COATED BALLOON, A CUTTING/SCORING BALLOON, AND A COILING/EMBOLIZATION DEVICE, WHICH RESULTED IN A FINAL RESIDUAL STENOSIS OF 10%. FURTHERMORE, APPROXIMATELY ONE YEAR, EIGHT MONTHS, AND FOUR DAYS AFTER THE INDEX PROCEDURE, THE SUBJECT EXPERIENCED AN ADVERSE EVENT OF PATIENT DEATH DUE TO AN UNKNOWN CAUSE. THE ADVERSE EVENT¿S RELATEDNESS TO THE DEVICE AND PROCEDURE WAS NOT REPORTED. IT WAS NOTED THAT THE ADVERSE EVENT, DEATH WAS NOT RELATED T

  Patient problems: Stenosis

  MAUDE report 23739256 ↗
• MalfunctionNov 27, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR ARTERIOVENOUS FISTULA PROCEDURE USING WAVELINQ. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE CATHETER GOT KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665240 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT TWO WEEKS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. REPORTEDLY, SECOND STAGE PROCEDURE WAS PERFORMED DUE TO STENOSIS ON THE RADIAL VEIN AT THE PERI-ANASTOMOTIC LOCATION TO SUPPORT MATURATION OF THE ARTERIALIZED VEIN SEGMENTS BY EMBOLIZATION COIL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23520121 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FIVE MONTHS AND FIFTEEN DAYS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, PATIENT DEVELOPED ULNAR ARTERY STENOSIS WHICH WAS OBSERVED AT UNSCHEDULED VISIT TWO. IT WAS ALSO REPORTED THAT TWO PREVIOUS SECOND STAGE PROCEDURES PERFORMED PRIOR TO THIS STENOSIS. FURTHER ASSESSMENTS ON SIXTH MONTH FOLLOW-UP REVEALED THAT THE ENDOAVF HAS MATURED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23400905 ↗
• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION PROCEDURE, THE SUBJECT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOR CEPHALIC VEIN CIRCUIT STENOSIS WITH INITIAL STENOSIS OF 90% AND FINAL RESIDUAL STENOSIS OF 10%. IT WAS FURTHER REPORTED THAT APPROXIMATELY ONE MONTH AND FOUR DAYS POST ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. IT WAS FURTHER REPORTED THAT THE SUBJECT UNDERWENT SECOND STAGE PROCEDURE OF BALLOON ASSISTED MATURATION TO SUPPORT CANNULATION OF THE ARTERIALIZED VEIN SEGMENTS ON THE RADIAL ARTERY STENOSIS WITH INITIAL STENOSIS OF 70% AND FINAL RESIDUAL STENOSIS OF 10%. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23140262 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT SIX WEEKS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION USING THE WAVELINQ 4FR P, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE, BY PHYSICAL ASSESSMENT. REPORTEDLY, THIRTY-SEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT SECOND STAGE PROCEDURE OF ARTERIOGRAM-SALVAGE ATTEMPT TO SUPPORT MATURATION OF THE ARTERIALIZED VEIN SEGMENTS ON THE BRACHIAL VEIN. REPORTEDLY, THE ENDOAVF WAS PERMANENTLY ABANDONED DUE TO NO LONGER VIABLE AND ONLY DEEP VEINS MATURED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22824888 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) CONNECT AV) OF COMMERCIALLY AVAILABLE WAVELINQ DEVICE, THAT ONE MONTH TWO WEEKS THREE DAYS POST-ENDOVASCULAR ARTERIOVENOUS FISTULA CREATION, THE ENDOVASCULAR ARTERIOVENOUS FISTULA WAS ALLEGEDLY FOUND TO BE NOT MATURED WITHIN THREE MONTHS OF INDEX PROCEDURE. THE ADVERSE EVENT WAS POSSIBLY RELATED TO PROCEDURE AND DEFINITELY RELATED TO AV ACCESS CIRCUIT AND NOT RELATED TO PROCEDURE. IT WAS FURTHER REPORTED THAT DIALYSIS WAS PERFORMED IN THE ARTERIOVENOUS FISTULA BY USING ONE NEEDLE DUE TO DIFFICULT CANNULATION POST INDEX PROCEDURE. REPORTEDLY, PATIENT DEVELOPED UPPER ARM SWELLING DUE TO MINOR INFILTRATION INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Swelling/ Edema

  MAUDE report 22781081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192239. One submission often covers many models, so check the product and lot details in each record.

• Z-2085-2014 · Jun 13, 2014 · Terminated
  GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.