Sleek OTW PTA Dilatation Catheter 426-2022XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741133626), received between Feb 9, 2018 and Dec 8, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Stretched; Difficult to Open or Remove Packaging Material; Break; Stretched; Difficult to Open or Remove Packaging Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE SLEEK OTW PTA CATHETER. UPON OPENING, THE SLEEVE DID NOT SEPARATE FROM THE BALLOON. HE TRIED TO PULL IT, WHICH RESULTED IN DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23738527 ↗
• MalfunctionOct 21, 2020Material Rupture; Stretched; Detachment of Device or Device Component; Material Rupture; Stretched; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-2022X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RUPTURE AND DETACHMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715048 ↗
• MalfunctionJul 30, 2020Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY DRAGGED AND STUCK WHEN TRYING TO REMOVE THE CATHETER. IT WAS FURTHER REPORTED THAT THE DOCTOR LOST WIRE PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342611 ↗
• MalfunctionJul 17, 2018Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697140 ↗
• MalfunctionMar 27, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE SECOND INFLATION. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374109 ↗
• MalfunctionFeb 9, 2018Material Rupture; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260357 ↗