MAXI LD 4162540LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032002391), received between Feb 28, 2020 and Mar 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE MAXI LD PTA F7 110 25X40 BALLOON DILATATION CATHETER WAS USED. HOWEVER, WHEN INFLATED AT 3 ATMOSPHERES (ATM), CONTRAST MEDIA LEAKAGE WAS CONFIRMED. JUDGED AS A BALLOON RUPTURE AND IT WAS REMOVED FROM THE PATIENT BODY. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW MAXI LD AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE INFERIOR VENA CAVA WITH STENOSIS. A DEVICE WAS STORED IN-HOSPITAL SANITARY AREA STORAGE. IT WAS OPENED CATH ROOM AND APPEARANCE. NO DAMAGE WAS SEEN ON THE STERILIZATION BAG. COMPLETED DEVICE FLUSHING AND DEFLATING. THEY¿VE CHECKED THE STENOSIS PART AND PRE-DILATION WAS PERFORMED WITH A NON-CORDIS BALLOON CATHETER SECOND TIME. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED DUE TO HOSPITAL REGULATION. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495912 ↗
• MalfunctionMar 17, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS LEAKAGE FROM 25X40 110 MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR CRIMPING HOWEVER, THE PRESSURE WAS NOT RISING. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) CASE. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY AND ATTEMPTED TO BE INFLATE OUTSIDE THE BODY AND FOUND OUT THAT THE CONTRAST MEDIA WAS LEAKING FROM THE BONDED PART OF THE BALLOON EDGE THAT¿S WHY THE PRESSURE WAS NOT RISING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED TO THE HOSPITAL DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844767 ↗
• MalfunctionMar 4, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) CASE, A 7F 110CM 25MM X 40CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED TO INFLATE A GRAFT BUT WHEN PRESSURE WAS APPLIED IT DID NOT INFLATE. IT WAS DETERMINED TO BE A RUPTURE. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE BALLOON CATHETER WAS REMOVED EASILY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED IN THE HOSPITAL. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY 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 INTO THE PATIENT. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786655 ↗
• MalfunctionFeb 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7F 25 X 40 110 MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT INFLATE UPON INFLATION DURING A PROCEDURE AND BALLOON RUPTURE WAS CONFIRMED. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT (IN ONE PIECE) FROM THE PATIENT. IT WAS THEN REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE LESION WAS MILDLY CALCIFIED. THERE WAS ALMOST NO VESSEL TORTUOSITY NOTED. THERE WAS NO STENOSIS. THE DEVICE WAS STORED AND HANDLED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY 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 INTO THE PATIENT. THE DEVICE WAS PREPPED AS PER IFU. THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770150 ↗