MAXI LD 4171460SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032002452), received between Apr 3, 2023 and Jun 9, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 14MM X 6CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS CAUGHT DURING THE PROCEDURE AND FELL OFF. THE BALLOON WAS CAUGHT DURING REMOVAL FROM A NON-CORDIS STENT AND THE SEPARATION OCCURRED WHILE TRYING TO WITHDRAW THE BALLOON CATHETER. THERE WERE ATTEMPTS TO RETRIEVE THE SEPARATED SEGMENT FROM THE PATIENT USING AN UNKNOWN DEVICE; HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL, AND THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL FOR SURGERY. THE SEPARATED SEGMENT WAS SUCCESSFULLY REMOVED DURING THE SURGICAL INTERVENTION. THE TARGET VESSEL WAS THE ILIAC VEIN, WHICH WAS NEITHER CALCIFIED NOR TORTUOUS. THE SEPARATION OCCURRED IN THE ILIAC VEIN. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168095 ↗
• MalfunctionApr 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE USE OF A 14X6 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON IMMEDIATELY RUPTURED DURING AN ATTEMPTED INFLATION AND THE BALLOON WAS UNABLE TO BE PRESSURIZED. AS A RESULT, A NEW 14X6 80CM MAXI LD PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED TO POST DILATE AN UNKNOWN VENOUS STENT. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. A 1:2 CONTRAST TO SALINE RATIO WAS USED TO PREP THE BALLOON. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665737 ↗