MAXI LD 4171640SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20705032002568), received between Jun 30, 2019 and Jan 19, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF A 16MM X 6CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND A 16MM X 4CM MAXI LD PTA BALLOON CATHETER RUPTURED WHEN DEPLOYED THROUGH AN UNKNOWN STENT. THERE WERE NO REPORT INJURIES TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545426 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, TWO 7F 16X4 MAXI LD BALLOONS RUPTURED DURING POST DILATATION OF VENOUS STENT. THE BALLOONS WERE ONLY INFLATED TO 4 ATM BEFORE RUPTURING. UPON REMOVAL OF THE SECOND DEVICE, THE BALLOON COMPLETELY SEPARATED. THIS OCCURRED WHILE TRYING TO REMOVE THE BALLOON FROM THE SHEATH. THE SHEATH HAD TO BE REMOVED WITH BALLOON AND WIRE, SHEATH THEN HAD TO BE CUT OPEN TO REMOVE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS AN IMAGE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794245 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, TWO 7F 16X4 MAXI LD BALLOONS RUPTURED DURING POST DILATATION OF VENOUS STENT. THE BALLOONS WERE ONLY INFLATED TO 4 ATM BEFORE RUPTURING. UPON REMOVAL OF THE SECOND DEVICE, THE BALLOON COMPLETELY SEPARATED. THIS OCCURRED WHILE TRYING TO REMOVE THE BALLOON FROM THE SHEATH. THE SHEATH HAD TO BE REMOVED WITH BALLOON AND WIRE, SHEATH THEN HAD TO BE CUT OPEN TO REMOVE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS AN IMAGE WAS PROVIDED. THE PICTURE SHOWS THE DISTAL SECTION OF THE 2 UNITS. SAMPLE # 1, IT COULD BE NOTICED THE BALLOON DEFLATED AND BLOOD RESIDUES. SAMPLE # 2, IT COULD BE NOTICED THE BALLOON BURST AND SEPARATED. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED AT THE ATTACHED PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794241 ↗
• MalfunctionJun 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE MAXI LD 7F 16X4 BALLOON BURST AT 5ATM IN THE ILIAC VEIN. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE USE OF A NEW 16X40 MAXI. THE BALLOON DID RUPTURE WHILE IN THE VESSEL AND WHILE IN A STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE INTENDED LESION WAS IN THE ILIAC VEIN. THE LESION DID NOT HAVE ANY CALCIFICATION AND THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE LESION WAS NOTED TO HAVE A 50% STENOSIS. THE DEVICE WAS NO USED TO TREAT A CHRONIC TOTAL OCCLUSION. THE NON-CORDIS INFLATION DEVICE WAS FILLED WITH A 50/50 SALINE/CONTRAST RATIO. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE. A NON-CORDIS WIRE CROSSED THE LESION. (SIZE/LOT NOT KNOWN). THERE WAS NO RESISTANCE/FRICTION NOTED WHILE THE DEVICE WAS INSERTED THROUGH THE ROTATING HEMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14792936 ↗
• InjuryMar 15, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A MAXI LD 7F 16X4 RUPTURED IN THE ILIAC VEIN WHEN TRYING TO POST DILATE A NEWLY IMPLANTED (UNKNOWN) STENT. THE BALLOON WAS NOTED TO BE IN FRAGMENTS AND WERE REMOVED USING A SNARE THROUGH AN UNKNOWN PROCEDURAL SHEATH. THE DEVICE WAS REMOVED FROM THE PATENT IN MULTIPLE PIECES. THERE WAS NO REPORTED INJURY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING STYLET. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. NEGATIVE PRESSURE WAS MAINTAINED DURING PREP. THE BALLOON WAS BEING USED FOR DILATATON OF THE LEFT COMMON ILIAC VEIN STENT. THE LESION WAS NOTED NOT TO HAVE ANY CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. THE STENOSIS WAS NOTED TO BE ABOUT 54%. THE DEVICE WAS NOT BEING USED FOR CHRONIC TOTAL OCCLUSION. THE BALLOON BURST AT 4ATM. THE INFLATION DEVICE WAS FILLED WITH 50/50 CONTRAST/SALINE. THE INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772568 ↗
• 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 8850847 ↗
• 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 8850630 ↗
• MalfunctionJun 30, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THREE MAXI LD BALLOON CATHETERS BURST AT ONE ATMOSPHERE (1 ATM) DURING THE INITIAL INFLATION. THERE WAS NO PATIENT INJURY. A COMPETITOR'S BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH A ONE TO FOUR RATIO. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746800 ↗
• MalfunctionJun 30, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THREE MAXI LD BALLOON CATHETERS BURST AT ONE ATMOSPHERE (1 ATM) DURING THE INITIAL INFLATION. THERE WAS NO PATIENT INJURY. A COMPETITOR'S BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH A ONE TO FOUR RATIO. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746799 ↗
• MalfunctionJun 30, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THREE MAXI LD BALLOON CATHETERS BURST AT ONE ATMOSPHERE (1 ATM) DURING THE INITIAL INFLATION. THERE WAS NO PATIENT INJURY. A COMPETITOR'S BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WAS USED WITH A ONE TO FOUR RATIO. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746798 ↗