Sleek PTA Dilatation Catheter 425-2512XRecalls & reported problems
Clearstream Technologies Limited · Sleek PTA Dilatation Catheter 2.5mm x 120mm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741132377), received between May 9, 2018 and Jan 9, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Rupture2
- Device Contamination with Chemical or Other Material1
- Failure to Advance1
- Material Deformation1
- Packaging Problem1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A HAIR WAS ALLEGEDLY FOUND IN THE STERILE PACKAGING OF THE BALLOON CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18473179 ↗MalfunctionJan 13, 2021Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PROXIMAL CATHETER END ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD RETRACTION ISSUE WHEN REMOVING FORM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11162515 ↗MalfunctionJul 11, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 425-2512X PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8783096 ↗MalfunctionJul 23, 2018Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem
IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE PACKAGING HOOP. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER PULLED ON THE CATHETER CAUSING THE CATHETER TO STRETCH. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7712775 ↗MalfunctionMay 9, 2018Material Rupture; Failure to Advance; Material Rupture; Failure to Advance
IT WAS REPORTED THAT DURING TREATMENT OF A CTO BEHIND THE KNEE LESION WITH AN IPSILATERAL APPROACH, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT CROSS THE LESION. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7499904 ↗
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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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