LUTONIX Drug Coated BalloonRecalls & reported problems across all models

We found 107 models of LUTONIX Drug Coated Balloon by Lutonix, Inc. in the FDA's device registry (GUDID). Together they are named in 997 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2015 and Sep 23, 2026 — classified as 1 death, 753 injuries, 243 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (126 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. 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

Most reported LUTONIX Drug Coated Balloon problems

LUTONIX Drug Coated Balloon models

107 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• LUTONIX® Drug Coated Balloon LX351305150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  117 reports
• LUTONIX® Drug Coated Balloon LX351306150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  75 reports
• Lutonix® Drug Coated Balloon LX351305100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  66 reports
• Lutonix® Drug Coated Balloon LX35130560

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  45 reports
• Lutonix® Drug Coated Balloon LX351306100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  40 reports
• LUTONIX® Drug Coated Balloon LX351304150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  37 reports
• Lutonix® Drug Coated Balloon LX351304100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  36 reports
• LUTONIX® Drug Coated Balloon LX351305120

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  32 reports
• LUTONIX® Drug Coated Balloon LX1813062205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  27 reports
• LUTONIX® Drug Coated Balloon LX3513061505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  24 reports
• Lutonix® Drug Coated Balloon LX35130660

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  23 reports
• LUTONIX® Drug Coated Balloon LX351306120

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  22 reports
• LUTONIX® Drug Coated Balloon LX3513051505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  22 reports
• LUTONIX® Drug Coated Balloon LX1813063005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  22 reports
• Lutonix® Drug Coated Balloon LX35130640

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  19 reports
• Lutonix® Drug Coated Balloon LX35130580

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  19 reports
• Lutonix® Drug Coated Balloon LX35130540

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  18 reports
• Lutonix® Drug Coated Balloon LX35130460

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  14 reports
• Lutonix® Drug Coated Balloon LX35130680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  14 reports
• LUTONIX® Drug Coated Balloon LX1813052205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  13 reports
• LUTONIX® Drug Coated Balloon LX1813072205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  13 reports
• LUTONIX® Drug Coated Balloon LX3513041505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  12 reports
• LUTONIX® Drug Coated Balloon LX3513061005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  12 reports
• LUTONIX® Drug Coated Balloon LX1813053005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  12 reports
• Lutonix® Drug Coated Balloon LX35130440

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  11 reports
• LUTONIX® Drug Coated Balloon LX3513052205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  10 reports
• Lutonix® Drug Coated Balloon LX35130480

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• LUTONIX® Drug Coated Balloon LX3513051005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• LUTONIX® Drug Coated Balloon LX351306605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  9 reports
• LUTONIX® Drug Coated Balloon LX351006150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• LUTONIX® Drug Coated Balloon LX351305605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• LUTONIX® Drug Coated Balloon LX3513061205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• LUTONIX® Drug Coated Balloon LX351306805F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  8 reports
• LUTONIX® Drug Coated Balloon LX35756605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 death7 reports
• LUTONIX® Drug Coated Balloon LX351005150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• LUTONIX® Drug Coated Balloon LX35755405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• LUTONIX® Drug Coated Balloon LX351306405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• LUTONIX® Drug Coated Balloon LX351307405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• LUTONIX® Drug Coated Balloon LX1813061505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  6 reports
• LUTONIX® Drug Coated Balloon LX351004150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• LUTONIX® Drug Coated Balloon BSCLX351306150

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• LUTONIX® Drug Coated Balloon LX357551505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• LUTONIX® Drug Coated Balloon LX351305405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• LUTONIX® Drug Coated Balloon LX351307605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  5 reports
• Lutonix® Drug Coated Balloon LX351005100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• LUTONIX® Drug Coated Balloon LX351305805F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• LUTONIX® Drug Coated Balloon LX3513051205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• LUTONIX® Drug Coated Balloon LX3513042205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• LUTONIX® Drug Coated Balloon LX3575780V

  Drug-coated peripheral transluminal angioplasty catheter
  4 reports
• Lutonix® Drug Coated Balloon LX35100580

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Lutonix® Drug Coated Balloon LX35100680

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Lutonix® Drug Coated Balloon BSCLX35130560

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Lutonix® Drug Coated Balloon BSCLX35130660

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX357541505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX35755805F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX357551005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX35757605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX351304605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX351304805F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX3513041005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX3513062205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX3513071505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX3513072205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• LUTONIX® Drug Coated Balloon LX181307405F

  Drug-coated peripheral transluminal angioplasty catheter
  3 reports
• Lutonix® Drug Coated Balloon LX3575640

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Lutonix® Drug Coated Balloon LX35100460

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Lutonix® Drug Coated Balloon LX35100660

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Lutonix® Drug Coated Balloon LX351006100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon BSCLX351306120

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon BSCLX351305150

  Sacroiliac joint fixation
  2 reports
• LUTONIX® Drug Coated Balloon LX35755605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX35756405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX357561505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX35757405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX351304405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX1813051505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX181306605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• LUTONIX® Drug Coated Balloon LX3575740

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX3575460

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX3575660

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX35100440

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX35100640

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX35100480

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon LX351004100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX351006120

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon BSCLX35130440

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Lutonix® Drug Coated Balloon BSCLX351306100

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon BSCLX35130760

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX35754405F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX35756805F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX357561005F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX357561205F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon BSLX3513051505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon BSLX3513061505F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon BSLX351307605F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX1810041504F

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• LUTONIX® Drug Coated Balloon LX1810062205F

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• LUTONIX® Drug Coated Balloon LX1813041004F

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• LUTONIX® Drug Coated Balloon LX1813041504F

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• LUTONIX® Drug Coated Balloon LX1813042204F

  Drug-coated peripheral transluminal angioplasty catheter
  1 report

Recent LUTONIX Drug Coated Balloon adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Inflation Problem; Material Twisted/Bent

  On (b)(6) 2026, a patient underwent an angioplasty procedure using a Lutonix Drug Coated Balloon. During the procedure, a twist was observed in the middle of the balloon. The healthcare professional inflated, deflated, and reinflated the balloon; however, the kink did not resolve. The device was removed from the patient, and the kink was subsequently straightened on the back table. The balloon was not reused on the patient. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866460 ↗
• MalfunctionApr 8, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6), 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY TWISTED DURING INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814083 ↗
• MalfunctionMar 16, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A 60-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY TWISTED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603600 ↗
• MalfunctionMar 10, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WRAPPED. FURTHER, INFLATION PROBLEM WAS REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555172 ↗
• MalfunctionMar 10, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WRAPPED. FURTHER, INFLATION PROBLEM WAS REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555167 ↗
• MalfunctionMar 2, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING THE LUTONIX DRUG COATED BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481187 ↗
• MalfunctionFeb 13, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331455 ↗
• MalfunctionFeb 13, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY HAD A HOLE IN IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330977 ↗
• MalfunctionFeb 9, 2026Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2026, AN 80 YEAR OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE LUTONIX 018 DRUG COATED BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY TWISTED AND WAS TROUBLE DEFLATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289671 ↗
• MalfunctionFeb 5, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE LUTONIX 018 DRUG COATED BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY TWISTED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265380 ↗
• MalfunctionFeb 5, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WRAPPED IN DEPLOYMENT AND NOT INFLATE FULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265302 ↗
• MalfunctionJan 30, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE LUTONIX 035 DRUG COATED BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219491 ↗
• MalfunctionDec 12, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG-COATED BALLOON ANGIOPLASTY (DCB) PROCEDURE USING THE LUTONIX 018 DRUG-COATED DILATATION CATHETER. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY FAILED INFLATE, LEAVING A SMALL PINCH IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788174 ↗
• MalfunctionDec 8, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING LUTONIX 018 DRUG COATED DILATATION CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY FAILED TO OPEN FULLY LEAVING A SMALL PINCH ON THE BALLOON. FURTHER, THE BALLOON WAS INFLATED AND DEFLATED AGAIN TO GET THE AREA TO OPEN AND WAS FURTHER SLIGHTLY OVER-INFLATED WHEN IT WAS FULLY OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740432 ↗
• InjuryDec 1, 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 POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER FOR TARGET LESION STENOSIS ON THE LEFT UPPER ARM CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT FOREARM SWELLING AND FINGERTIP NUMBNESS AND NO PAIN. REPORTEDLY, THE ADVERSE EVENT DOESN'T MEET THE DEFINITION OF SERIOUS AND DOESN'T RESULT IN AV ACCESS CIRCUIT RE-INTERVENTION. THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. IT WAS FURTHER REPORTED THAT APPROXIMATELY NINE MONTHS AND TWO WEEKS POST AN INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT ARM AVF BLOCKAGE AND THROMBOSIS OF LEFT BRACHIOCEPHALIC AVF. REPORTEDLY, THE SUBJECT UNDERWENT OPEN LEFT CEPHALIC VEIN THROMBECTOMY PROCEDURE. THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Numbness; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 23677654 ↗

Other Lutonix, Inc. products

• LUTONIX 035 Drug Coated Balloon PTA Catheter19 models · 243 reports