Sleek OTW PTA Dilatation Catheter 426-2522XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741133701), received between Jul 16, 2019 and May 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON (B)(6) 2024, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING A SLEEK OTW PTA CATHETER. PRIOR TO THE PROCEDURE, THE PTA BALLOON CATHETER FELL APART AND DISASSEMBLED WHEN REMOVING THE PROTECTIVE BALLOON COVER. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076218 ↗
• MalfunctionFeb 24, 2025Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, AFTER REMOVING THE BALLOON SLEEVE THE BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. IT WAS FURTHER REPORTED THAT A BREAK WAS CONFIRMED AT THE BALLOON TAPER POINT AND THE CATHETER OUTER SHAFT. IT WAS FURTHER REPORTED THAT THERE WAS EVIDENCE OF INNER STRETCHED WITHIN THE BREAK AREA. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444597 ↗
• MalfunctionMar 14, 2024Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE TIBIAL FEMORAL ARTERY VIA THE COMMON FEMORAL ARTERY, THE DILATATION CATHETER WAS ALLEGEDLY STRIPPED RIGHT OFF THE SHAFT WHEN THE SCRUB TECHNICIAN REMOVED THE BALLOON FROM THE PLASTIC BALLOON HOUSING. IT WAS FURTHER REPORTED THAT THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY OF THE STERILE PACKAGING COMPONENTS. REPORTEDLY, THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT AND THE BALLOON WAS NOT CAUGHT IN THE LESION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902795 ↗
• MalfunctionJul 15, 2020Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 426-2522X PTA CATHETER ALLEGEDLY EXPERIENCED PACKAGING PROBLEM, MATERIAL DEFORMATION AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10279918 ↗
• MalfunctionJul 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2522X PTA CATHETER EXPERIENCED AN ALLEGED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MATERIAL RUPTURE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795521 ↗