Sleek PTA Dilatation Catheter 425-2504XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 2.5mm x 40mm balloon, 150cm shaft · Class 2
All models of Sleek PTA Dilatation Catheter (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741132308), received between Feb 13, 2018 and Jan 10, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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
Device problems
- Material Rupture3
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT POSTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED ON SECOND INFLATION AT 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13203010 ↗MalfunctionJul 16, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2504X PTA DILATATION CATHETER EXPERIENCED A 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 8795407 ↗MalfunctionFeb 13, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED DURING TREATMENT IN A SEVENTY PERCENT STENOSIS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7268624 ↗
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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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