Sleek OTW PTA Dilatation Catheter 426-1508XRecalls & reported problems
Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 1.5mm x 80mm balloon, 150cm shaft · Class 2
All models of Sleek OTW PTA Dilatation Catheter (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741133534), received between May 30, 2018 and Jul 22, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (10 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture10
- Stretched8
- Material Deformation7
- Break4
- Detachment of Device or Device Component3
- Failure to Advance2
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Break; Material Rupture; Stretched; Material Deformation; Break; Material Rupture; Stretched; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING A SLEEK OTW PTA CATHETER. PRIOR THE PROCEDURE, THE SLEEK BALLOON IT WAS FOUND TO BE BROKEN INTO TWO SEGMENTS AND UNUSABLE. A NEW SLEEK BALLOON WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563032 ↗MalfunctionJun 16, 2025Break; Stretched; Material Deformation; Break; Stretched; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE SLEEK OTW PTA CATHETER. PRIOR TO THE PROCEDURE, THE BALLOON WAS REMOVED FROM THE TRAY AND FOUND TO BE BROKEN INTO 3 SECTIONS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210069 ↗MalfunctionAug 11, 2021Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY BROKEN WHILE PASSING THROUGH THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306351 ↗MalfunctionApr 30, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND PROXIMAL END LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11751342 ↗MalfunctionMar 23, 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 11548605 ↗MalfunctionOct 30, 2020Material Rupture; Stretched; Material Rupture; Stretched
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL 426-1508X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE, AND STRETCHED MATERIAL. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED PATIENTS WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX, AND WEIGHT WERE UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10760106 ↗MalfunctionOct 20, 2020Material Rupture; Stretched; Detachment of Device or Device Component; Material Deformation; Material Rupture; Stretched; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10703576 ↗MalfunctionJul 15, 2020Material Rupture; Stretched; Material Rupture; Stretched
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-1508X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND STRETCHING. 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 10279876 ↗MalfunctionJan 13, 2020Stretched; Failure to Advance; Detachment of Device or Device Component; Stretched; Failure to Advance; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-1508X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE, DETACHMENT, AND STRETCHING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9583862 ↗MalfunctionJan 13, 2020Material Rupture; Stretched; Failure to Advance; Material Rupture; Stretched; Failure to Advance
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 426-1508X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, MATERIAL DEFORMATION, FAILURE TO ADVANCE AND IT WAS STRETCHED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCE'S. AGE, GENDER AND WEIGHT WAS NOT PROVIDED FOR THE REPORTED PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9582938 ↗MalfunctionOct 18, 2019Material Rupture; Stretched; Material Deformation; Material Rupture; Stretched; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 426-1508X ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9211408 ↗MalfunctionJan 4, 2019Material Rupture; Material Deformation; Material Split, Cut or Torn; Material Rupture; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8218396 ↗MalfunctionNov 8, 2018Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING THE PROCEDURE THE SHAFT OF THE PTA DILATATION CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8053220 ↗MalfunctionMay 30, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7553640 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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