Sleek PTA Dilatation Catheter 425-2515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741132384), received between May 4, 2018 and Oct 21, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 18, 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.

• MalfunctionOct 21, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2515X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED KINK AROUND THE BALLOON. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DOES NOT INVOLVED PATIENT. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10714694 ↗
• MalfunctionOct 9, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PTA BALLOON ALLEGEDLY KINKED AND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656875 ↗
• MalfunctionOct 11, 2019Leak/Splash; Material Rupture; Device-Device Incompatibility; Leak/Splash; Material Rupture; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE INFORMATION INDICATED THAT MODEL 425-2515X PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED, LEAKED, AND EXPERIENCED DEVICE-DEVICE INCOMPATIBILITY. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182921 ↗
• MalfunctionApr 19, 2019Break; Material Deformation; Break; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 425-2515X PTA DILATATION CATHETER ALLEGEDLY HAD A SHAFT BREAK AND MATERIAL DEFORMATION. THIS REPORT WAS RECEIVED FROM ONE SOURCES. THE DEVICE WAS USED IN THE PATIENT, WITH NO PATIENT INJURY REPORTED. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533459 ↗
• MalfunctionJan 8, 2019Device Damaged Prior to Use; Detachment of Device or Device Component; Material Split, Cut or Torn; Device Damaged Prior to Use; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE PTA BALLOON DILATATION CATHETER WAS ALLEGEDLY IDENTIFIED TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8227122 ↗
• MalfunctionJan 8, 2019Device Damaged Prior to Use; Detachment of Device or Device Component; Material Deformation; Device Damaged Prior to Use; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION, THE PTA DILATATION CATHETER WAS ALLEGEDLY TORN AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8226889 ↗
• MalfunctionJul 18, 2018Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PTA BALLOON FAILED TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699480 ↗
• MalfunctionMay 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7489105 ↗