Sleek PTA Dilatation Catheter 425-2522XRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741132407), received between Jul 3, 2018 and May 18, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2023Difficult to Remove; Component Missing; Detachment of Device or Device Component; Difficult to Remove; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND TO BE MISSING INSIDE THE BOX. REPORTEDLY, THE BOX WAS EMPTY. THERE WAS NO PATIENT CONTACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951150 ↗
• MalfunctionOct 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726247 ↗
• MalfunctionOct 21, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 425-2522X PTA DILATATION CATHETER ALLEGEDLY MATERIAL TWISTED/BENT AND MATERIAL DEFORMED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10714693 ↗
• MalfunctionOct 21, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 425-2522X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THE INFORMATION WAS RECEIVED FROM A SINGLE 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 10714690 ↗
• MalfunctionJul 15, 2020Break; Device Damaged Prior to Use; Material Deformation; Break; Device Damaged Prior to Use; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2522X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEVICE DAMAGED, BROKE AND MATERIAL DEFORMED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT AGE WEIGHT AND GENDER WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10279860 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2522X RX PTA CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO MATERIAL RUPTURES, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WAS NOT REPORTED FOR EITHER OF THE PATIENTS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783290 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Deformation; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 425-2522X PTA BALLOON DILATATION CATHETER EXPERIENCED A MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533001 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Deformation; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 425-2522X DILATATION CATHETER EXPERIENCED A MATERIAL RUPTURE AND MATERIAL DEFORMATION. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532926 ↗
• MalfunctionMar 11, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER WAS ALLEGEDLY TWISTED. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409955 ↗
• MalfunctionOct 29, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION, UPON LOADING THE BALLOON CATHETER ONTO THE GUIDEWIRE THE DISTAL TIP OF THE PTA DILATATION BALLOON CATHETER WAS ALLEGEDLY FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8017059 ↗
• MalfunctionSep 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED BELOW RATED BURST PRESSURE (RBP). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912101 ↗
• MalfunctionAug 31, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PTA DILATATION CATHETER ALLEGEDLY BENT AND KINKED DURING USE IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838201 ↗
• MalfunctionAug 30, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PTA DILATATION CATHETER WAS ALLEGEDLY BENT/TWISTED AND KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7834367 ↗
• MalfunctionJul 13, 2018Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE IN THE TIBIAL ARTERY VIA AN IPSILATERAL APPROACH, THE BALLOON SLEEVE WAS ALLEGEDLY UNABLE TO BE REMOVED. THEREFORE, A NEW PTA BALLOON CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7687102 ↗
• MalfunctionJul 3, 2018Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT DURING PROCEDURE PREPARATION, THE SLEEVE OF THE PTA BALLOON CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT UPON REMOVAL OF THE SLEEVE WITH FORCE, THE BALLOON ALLEGEDLY DETACHED FROM THE CATHETER RENDERING THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO THE COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7660180 ↗