Sleek PTA Dilatation Catheter 425-3022XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 3.0mm x 220mm balloon, 155cm 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 00801741132483), received between Mar 19, 2018 and Jan 7, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Break1
- Device-Device Incompatibility1
- Difficult to Insert1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY HAD MATERIAL DEFORMATION IDENTIFIED AS KINKED/TWISTED DURING USE. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8223733 ↗MalfunctionJan 7, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT AS THE HEALTHCARE PROFESSIONAL (HCP) WAS USING THE PTA BALLOON CATHETER IT ALLEGEDLY HAD MATERIAL DEFORMATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8222827 ↗MalfunctionMar 19, 2018Break; Difficult to Insert; Device-Device Incompatibility; Break; Difficult to Insert; Device-Device Incompatibility
IT WAS REPORTED THAT THE SHAFT OF THE PTA BALLOON CATHETER ALLEGEDLY BROKE DURING INSERTION THROUGH THE SHEATH. THE DEVICE WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE CATHETER THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7349597 ↗
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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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