MAXI LD 4171660SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032002582), received between Nov 13, 2018 and Jan 19, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 6 most recent of 6 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. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545341 ↗
• MalfunctionJan 16, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE MAXI LD 16X6 80CM BALLOON RUPTURED DURING THE PROCEDURE. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU).THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON INFLATED NORMALLY. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE BALLOON CATHETER WAS REMOVED EASILY. THE TARGET LESION WAS A FIBROUS ILIAC VEIN. A NON-CORDIS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252638 ↗
• MalfunctionDec 17, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING THE INITIAL INFLATION OF A MAXI LD BALLOON CATHETER RUPTURE. THERE WAS NO PATIENT INJURY. A SECOND BALLOON HAD TO BE USED TO FINISH THE ANGIOPLASTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169637 ↗
• MalfunctionNov 13, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING POST DILATION, IT WAS REPORTED THAT FOUR MAXI LD BALLOON CATHETER'S RUPTURE WITHIN THE STENT WHILE INFLATING WITHIN THE WALL STENT. THERE WAS NO PATIENT INJURY. THE USER FELT THAT THE BALLOONS WEREN'T WRAPPED AS WELL AS THEY USUALLY ARE AFTER THEY WERE REMOVED FROM THE PACKAGE. THIS ACCOUNT USES THESE BALLOONS FREQUENTLY AND IS VERY FAMILIAR WITH THE DEVICES. THE USER DOES NOT FEEL THAT THE BALLOON GOT CAUGHT ON A STENT STRUT WITHIN THE STENT AND RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066759 ↗
• MalfunctionNov 13, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING POST DILATION, IT WAS REPORTED THAT FOUR MAXI LD BALLOON CATHETER'S RUPTURE WITHIN THE STENT WHILE INFLATING WITHIN THE WALL STENT. THERE WAS NO PATIENT INJURY. THE USER FELT THAT THE BALLOONS WEREN'T WRAPPED AS WELL AS THEY USUALLY ARE AFTER THEY WERE REMOVED FROM THE PACKAGE. THIS ACCOUNT USES THESE BALLOONS FREQUENTLY AND IS VERY FAMILIAR WITH THE DEVICES. THE USER DOES NOT FEEL THAT THE BALLOON GOT CAUGHT ON A STENT STRUT WITHIN THE STENT AND RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066394 ↗
• MalfunctionNov 13, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING POST DILATION, IT WAS REPORTED THAT FOUR MAXI LD BALLOON CATHETER'S RUPTURE WITHIN THE STENT WHILE INFLATING WITHIN THE WALL STENT. THERE WAS NO PATIENT INJURY. THE USER FELT THAT THE BALLOONS WEREN'T WRAPPED AS WELL AS THEY USUALLY ARE AFTER THEY WERE REMOVED FROM THE PACKAGE. THIS ACCOUNT USES THESE BALLOONS FREQUENTLY AND IS VERY FAMILIAR WITH THE DEVICES. THE USER DOES NOT FEEL THAT THE BALLOON GOT CAUGHT ON A STENT STRUT WITHIN THE STENT AND RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066285 ↗