MAXI LD 4161540LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032002131), received between May 2, 2017 and Apr 26, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7F 15MM X 40MM X 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED FOR 30 SECONDS AT 4 ATMOSPHERES THREE TIMES. HOWEVER, IT RUPTURED DURING THIRD INFLATION. THE BLOOD VESSELS WERE WIDENED TO SOME EXTENT. SO, THE PROCEDURE WAS CONTINUED AS IT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS A CHILD. THE LESION WAS THE RIGHT PULMONARY ARTERY WITH STENOSIS. THE MAXI LD PTA BALLOON WAS USED FOR PRE-DILATION. THE MAXIMUM INFLATION PRESSURE WAS 4 ATMOSPHERES. THE DEVICE WAS STORED IN THE CATH LAB FOR ABOUT ONE MONTH. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE LESION WAS A LITTLE CALCIFIED, WITH A LITTLE TORTUOSITY. THERE WAS NINETY PERCENT STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728548 ↗
• MalfunctionFeb 15, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7F 15MM X 40MM X 110CM MAXI LARGE DIAMETER (LD) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED BUT IT RUPTURED. IT WAS REPLACED WITH ANOTHER DEVICE (UNKNOWN) AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY MISTAKE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327411 ↗
• MalfunctionNov 5, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 7F 15 X 40 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER RUPTURED DURING THE SECOND INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE IS LITTLE CALCIFICATION OF THE LESION AND VESSEL TORTUOSITY. THERE IS 70% STENOSIS. THE DEVICE WAS USED FOR A STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR WHILE REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS A LITTLE RESISTANCE/FRICTION FELT WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, BUT IT WAS NOT STRONG. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE MAXI LD WAS INTENDED TO BE USED FOR THREE SETS OF 30-SECOND INFLATIONS AT 4 ATMOSPHERE (ATM). THE DEVICE WAS USED TO IMPLANT A STENT. THE LESION WAS THE LEFT PULMONARY ARTERY WITH STENOSIS. THE BALLOON BURST AT 4 ATM. THE SAME INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280622 ↗
• MalfunctionAug 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS DELIVERED TO THE LESION FOR INFLATION. HOWEVER, IT RUPTURED DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THIS WAS AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) CASE. THE DEVICE WAS DISCARDED IN THE HOSPITAL DUE TO INFECTIOUS DISEASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939709 ↗
• MalfunctionJun 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7F MAXI LD PTA BALLOON CATHETER (110 15X40) WAS USED FOR A STENT GRAFT CASE; HOWEVER, IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707760 ↗
• MalfunctionApr 24, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE MAXI LD BALLOON CATHETER RUPTURED AT SIX ATMOSPHERES (6 ATM). THERE WAS NO PATIENT INJURY. THE LESION WAS THE ABDOMINAL AORTA WHICH HAD NINETY PERCENT (90%) STENOSIS AND WAS NOT CALCIFIED. A MAXI LD BALLOON WAS INSERTED AFTER A GUIDEWIRE CROSSED THE LESION. THE MAXI LD BALLOON WAS DELIVERED TO THE LESION. IT WAS USED PER THE INSTRUCTION FOR USE (IFU). HOWEVER, THE PRESSURE WAS NOT RAISING AFTER THE MAXI LD BALLOON WAS INFLATED AT 6 ATM. THEREFORE, THE MAXI LD BALLOON WAS REMOVED FROM THE PATIENT AND CONFIRMED THE BALLOON RUPTURE. 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 INFLATION DEVICE WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THE GUIDE CATHETER. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543933 ↗
• MalfunctionJan 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE MAXI PTA (F7 110 15X40) BALLOON CATHETER WAS RUPTURED DURING INFLATION, THEN THE DEVICE FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY. THE VESSEL LEVEL OF ANGULATION, CALCIFICATION AND TORTUOSITY IS NONE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS-1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON DID NOT INFLATE NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS 1-ATMOSPHERES PRESSURE (ATM). THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260622 ↗
• MalfunctionMay 2, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE MAXI LD F7 110 15X40 BALLOON CATHETER RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MAXI LD. THERE WAS NO PATIENT INJURY. THE DEVICE PREP NORMALLY. 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 INTO THE PATIENT. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND.  THE TARGET LESION IS THE ILIAC ARTERY.  THE INTENDED PROCEDURE IS THE ILIAC ARTERY OCCLUSION. THE CONTRAST MEDIA USED WAS BAYER WITH A CONTRAST TO SALINE RATIO 1:1. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS MMSI WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6536620 ↗