Sleek PTA Dilatation Catheter 425-2022XRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741132292), received between Jan 18, 2018 and Mar 21, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE INFRAPOPLITEAL LESION, THE PTA BALLOON ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580596 ↗
• MalfunctionFeb 20, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE POPLITEAL ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401975 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE DEVICE ALLEGEDLY BROKE DURING PREPARATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13704636 ↗
• MalfunctionDec 2, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915454 ↗
• MalfunctionAug 24, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359343 ↗
• MalfunctionOct 11, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2022X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182879 ↗
• MalfunctionOct 11, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2022X. PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND MATERIAL DEFORMATION (KINK). THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182875 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 425-2022X DILATATION CATHETER EXPERIENCED A MATERIAL RUPTURE. 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 8532928 ↗
• MalfunctionNov 5, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PTA BALLOON DILATATION CATHETER ALLEGEDLY DID NOT CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040235 ↗
• MalfunctionJun 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE IN THE ANTERIOR TIBIAL ARTERY, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED (ATM UNKNOWN). REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7636205 ↗
• MalfunctionApr 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PTA OF THE ANTERIOR TIBIAL ARTERY WITH A CONTRALATERAL APPROACH, THE BALLOON ALLEGEDLY RUPTURED AT 3 ATM. 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 7470852 ↗
• MalfunctionMar 6, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317733 ↗
• MalfunctionJan 18, 2018Material Rupture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203280 ↗