MAXI LD 4171860SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032002629), received between May 2, 2019 and Mar 10, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 16, 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.

• MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) 7F 18MM X 6MM X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS BURST DURING ANGIOPLASTY OF THE ILIAC VEIN. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION AT 4 ATMOSPHERES (ATM). THE DEVICES DID NOT INFLATE NORMALLY; LEAKAGE WAS NOTED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MODERATE TARGET LESION VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY. THE PERCENTAGE STENOSIS WAS NOT PROVIDED. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO VISIBLE VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICES PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINKS/BENDS NOTED AFTER THE DEVICES WERE REMOVED FROM PATIENT. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE DEVICES WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE USER IS TRAINED TO THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526465 ↗
• MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO (2) 7F 18MM X 6MM X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS BURST DURING ANGIOPLASTY OF THE ILIAC VEIN. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION AT 4 ATMOSPHERES (ATM). THE DEVICES DID NOT INFLATE NORMALLY; LEAKAGE WAS NOTED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MODERATE TARGET LESION VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY. THE PERCENTAGE STENOSIS WAS NOT PROVIDED. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. THERE WERE NO VISIBLE VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICES PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINKS/BENDS NOTED AFTER THE DEVICES WERE REMOVED FROM PATIENT. NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THE DEVICES WERE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE USER IS TRAINED TO THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526292 ↗
• MalfunctionDec 1, 2020Material Rupture; Material Rupture

  A 7F 18MM X 6MM X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED FROM THE PATIENT AND THE DEVICES. IT WAS ALSO REMOVED INTACT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927677 ↗
• MalfunctionAug 1, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN A 7F MAXI LD PTA BALLOON CATHETER (16X4 80CM) WAS ADVANCE WITHIN THE VENOUS STENT AND INFLATED (X2) AT THE PROXIMAL END OF THE STENT, THE MAXI BALLOON RUPTURED WITHIN THE STENT ON THE SECOND INFLATION. THEN, ANOTHER 7F MAXI LD PTA BALLOON CATHETER (16X4 80CM) WAS ADVANCE WITHIN THE SAME STENT AND THE BALLOON RUPTURED ON THE FIRST INFLATION; CONSEQUENTLY, THE PHYSICIAN ADVANCED 7F MAXI LD PTA BALLOON CATHETER (18X6 80CM) INTO THE SAME STENT AND INFLATED AT THE DISTAL END OF THE STENT (X2) AND THE BALLOON RUPTURED ON THE SECOND INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT ILIAC VEIN. THE VESSEL LEVEL OF ANGULATION, CALCIFICATION AND TORTUOSITY IS NONE. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES AND A 20-CC SYRINGE WAS USED. THE BALLOONS INFLATED NORMALLY FOR THE 1ST INFLATIONS BUT WOULD RUPTURE DURING SUBSEQUENT INFLATIONS. THE DEVICE WAS USED IN ILIAC VEIN, SO IT WAS INFLATED WITH 20CC SYRINGE AND JUST INFLATED ENOUGH TO OPPOSE THE STENT UP AGAINST THE WALL. THE CATHETERS WERE NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850886 ↗
• InjuryMay 2, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE MAXI LD 7F 18X6 80CM BALLOON RUPTURED IN THE PATIENT AND PARTS OF THE BALLOON WERE STUCK IN THE ILIAC VEIN. THE DOCTOR HAD TO CUT DOWN ON THE PATIENT AND RETRIEVE PIECES OF THE BALLOON FROM INSIDE THE VESSEL. THE DEVICE WAS STORED IN THE CATH LAB FOR ONE MONTH. THE PRODUCT WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NON DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE WAS THREE ATMOSPHERES. THE BA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574798 ↗