Sleek OTW PTA Dilatation Catheter 426-3022XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741133787), received between Sep 17, 2018 and Sep 30, 2026 — classified as 3 injuries, 6 malfunctions.

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

• MalfunctionSep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951855 ↗
• MalfunctionMar 3, 2026Deflation Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A TRANSLUMINAL ANGIOPLASTY OF THE LEFT LOWER LIMB USING THE SLEEK OTW BALLOON. THE BALLOON WAS INFLATED TO SIX ATMOSPHERES FOR A DURATION OF THREE MINUTES. UPON COMPLETION OF THE INFLATION PERIOD, BALLOON DEFLATION WAS ATTEMPTED HOWEVER, INITIAL DEFLATION WAS UNSUCCESSFUL DESPITE MULTIPLE ATTEMPTS. THE PROCEDURE REQUIRED REPLACEMENT OF THE INFLATION DEVICE TO FACILITATE FURTHER DEFLATION EFFORTS. AFTER APPROXIMATELY TEN MINUTES OF TOTAL INFLATION TIME, THE BALLOON WAS SUCCESSFULLY DEFLATED AND REMOVED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494365 ↗
• MalfunctionJul 31, 2025Break; Packaging Problem; Break; Packaging Problem

  ON (B)(6) 2025, DURING A PERIPHERAL VASCULAR ANGIOPLASTY PROCEDURE INVOLVING THE ANTERIOR TIBIAL ARTERY OF THE LOWER LIMB USING A SLEEK OTW PTA CATHETER. PRIOR TO VESSEL INSERTION, IT WAS OBSERVED THAT THE PROTECTIVE PLASTIC WAS ADHERED TO THE BALLOON, CAUSING DETACHMENT FROM THE DEVICE SHAFT AND RENDERING THE CATHETER UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673183 ↗
• InjuryDec 13, 2023Break; Deflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material; Material Deformation; No Apparent Adverse Event; Break; Deflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE BALLOON SLEEVE WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY WOULDN¿T DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 18316795 ↗
• MalfunctionDec 10, 2021Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY CAME OFF THE HUB WHILE TRYING TO REMOVE THE PROTECTIVE SLEEVE FROM THE PACKAGED BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974578 ↗
• MalfunctionOct 21, 2020Break; Deflation Problem; Material Rupture; Device-Device Incompatibility; Material Deformation; Break; Deflation Problem; Material Rupture; Device-Device Incompatibility; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-3022X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE AND BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10715186 ↗
• MalfunctionOct 11, 2019Break; Material Deformation; Break; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-3022X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT CONTACT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9182956 ↗
• InjuryMar 19, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PTA DILATION CATHETER ALLEGEDLY COULD NOT PASS THE LONG AND HEAVY STENOSIS ANTERIOR TIBIAL ARTERY (ATA) LESION. REPORTEDLY, IMMEDIATELY AFTER THE INFRAPOPLITEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (IP-PTA), ALLEGEDLY THERE WAS ARTERIAL PERFORATION AND EXCESSIVE BLOOD LOSS. FURTHERMORE, THE PERFORATION WAS TREATED WITH A PROLONGED BALLOON TAMPONADE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 8433911 ↗
• InjurySep 17, 2018Deflation Problem; Difficult to Advance; Material Deformation; Deflation Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT IN A CALCIFIED ANTERIOR TIBIAL LESION WITH EIGHTY FIVE PERCENT STENOSIS, THE PTA DILATION CATHETER WAS ALLEGEDLY DIFFICULT TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT AFTER THE HEALTH CARE PROVIDER (HCP) MANAGED TO CROSS THE LESION AND INFLATE THE BALLOON WITHOUT ISSUES, THE BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE WITH AN INFLATION DEVICE OR MULTIPLE SYRINGES. IT WAS ALSO ALLEGED THAT THE HCP PUNCTURED THE BALLOON WITH A 21G NEEDLE STICK THROUGH THE SKIN IN ORDER TO DEFLATE THE BALLOON, REMOVE THE CATHETER FROM THE PATIENT, AND COMPLETE THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882446 ↗