Sleek PTA Dilatation Catheter 425-2012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741132261), received between Mar 13, 2018 and Aug 3, 2022 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL APPROACH BELOW THE KNEE, THE SHAFT WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155118 ↗
• MalfunctionJul 15, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 425-2012X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND MATERIAL TWISTED AND BENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279718 ↗
• MalfunctionOct 18, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2012X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211410 ↗
• MalfunctionOct 11, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2012X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT¿S WEIGHT, AGE, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182877 ↗
• MalfunctionJul 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED (ATM UNKNOWN) TREATING A LESION IN THE LEFT SFA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733322 ↗
• MalfunctionJul 23, 2018Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER WAS ALLEGEDLY UNABLE TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712877 ↗
• MalfunctionJul 9, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PTA CATHETER ALLEGEDLY FAILED TO CROSS THE ANTERIOR TIBIAL ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672187 ↗
• MalfunctionJun 12, 2018Material Rupture; Material Rupture

  IT AS REPORTED THAT DURING A PTA PROCEDURE UTILIZING AN IPSILATERAL ANTEGRADE APPROACH OF THE ANTERIOR TIBIAL ARTERY WITH CALCIFICATION AND STENOSIS, THE BALLOON ALLEGEDLY RUPTURED. THE LESION WAS REPORTEDLY HARD. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594555 ↗
• MalfunctionMay 18, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE CATHETER ALLEGEDLY KINKED ON THE THIRD INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527908 ↗
• MalfunctionMar 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE DURING THE THIRD INFLATION IN THE HEAVY CALCIFIED LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7335277 ↗