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Sleek OTW PTA Dilatation Catheter 426-2015XRecalls & reported problems

Clearstream Technologies Limited · Sleek OTW PTA Dilatation Catheter 2.0mm x 150mm 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
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741133619), received between Oct 12, 2019 and Mar 2, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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

Device problems

  • Difficult to Remove2
  • Material Rupture2
  • Stretched2
  • Detachment of Device or Device Component1
  • Fracture1
  • Material Deformation1
  • Material Split, Cut or Torn1

Patient problems

  • No Consequences Or Impact To Patient2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 2, 2022Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE DEVICE ALLEGEDLY FRACTURED AND THE BALLOON WAS CAUGHT ON A PIECE OF CALCIUM, AND WOULD NOT DISLODGE. IT WAS FURTHER REPORTED THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO SURGICAL REMOVE THE DEVICE. THE CURRENT PATIENT STATUS WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13647640 ↗
  • InjuryFeb 28, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

    DURING USE, THE 2.0X150MM SLEEK OVER THE WIRE BALLOON CATHETER FRACTURED IN AN ANTERIOR TIBIAL ARTERY. THE BALLOON WAS CAUGHT ON A PIECE OF CALCIUM AND WOULD NOT DISLODGE. THIS CAUSED THE PATIENT TO BE TRANSFERRED TO (B)(6) HOSPITAL FOR SURGICAL REMOVE OF THE BALLOON. THERE WERE NO OTHER REPORTED COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13623257 ↗
  • MalfunctionOct 12, 2019Material Rupture; Stretched; Material Rupture; Stretched

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATED THAT MODEL 426-2015X, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A RUPTURE AND STRETCHED MATERIAL. THIS INFORMATION WAS RECEIVED FROM A SINGLE 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 9183031 ↗
  • MalfunctionOct 12, 2019Material Rupture; Stretched; Material Deformation; Material Rupture; Stretched; Material Deformation

    THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL 426-2015X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RUPTURE, STRETCHED MATERIAL, AND MATERIAL DEFORMATION. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9183012 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources and updates

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