Sleek OTW PTA Dilatation CatheterRecalls & reported problems across all models
Clearstream Technologies Limited · 24 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 24 models of Sleek OTW PTA Dilatation Catheter by Clearstream Technologies Limited in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2018 and Sep 30, 2026 — classified as 6 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Sleek OTW PTA Dilatation Catheter problems
Device problems
- Material Rupture40
- Material Deformation23
- Stretched22
- Detachment of Device or Device Component16
- Break15
- Deflation Problem9
- Difficult to Remove9
- Difficult to Open or Remove Packaging Material6
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient27
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Patient Involvement3
- Insufficient Information1
- Perforation of Vessels1
Sleek OTW PTA Dilatation Catheter models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sleek OTW PTA Dilatation Catheter 426-1508XCatheter, angioplasty, peripheral, transluminal14 reports
- Sleek OTW PTA Dilatation Catheter 426-3022XCatheter, angioplasty, peripheral, transluminal9 reports
- Sleek OTW PTA Dilatation Catheter 426-2022XCATHETER, PERCUTANEOUS6 reports
- Sleek OTW PTA Dilatation Catheter 426-1510XCatheter, angioplasty, peripheral, transluminal5 reports
- Sleek OTW PTA Dilatation Catheter 426-2522XCatheter, angioplasty, peripheral, transluminal5 reports
- Sleek OTW PTA Dilatation Catheter 426-1201XCatheter, angioplasty, peripheral, transluminal4 reports
- Sleek OTW PTA Dilatation Catheter 426-2015XCatheter, angioplasty, peripheral, transluminal4 reports
- Sleek OTW PTA Dilatation Catheter 426-1504XCATHETER, PERCUTANEOUS3 reports
- Sleek OTW PTA Dilatation Catheter 426-5010XCatheter, angioplasty, peripheral, transluminal3 reports
- Sleek OTW PTA Dilatation Catheter 426-1512XCATHETER, PERCUTANEOUS2 reports
- Sleek OTW PTA Dilatation Catheter 426-3008XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek OTW PTA Dilatation Catheter 426-3010XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek OTW PTA Dilatation Catheter 426-3015XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek OTW PTA Dilatation Catheter 426-5028XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek OTW PTA Dilatation Catheter 426-1501XCATHETER, PERCUTANEOUS1 report
- Sleek OTW PTA Dilatation Catheter 426-2010XCATHETER, PERCUTANEOUS1 report
- Sleek OTW PTA Dilatation Catheter 426-2012XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-2028XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-2504XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-2510XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-2512XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-4028XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek OTW PTA Dilatation Catheter 426-5004XCATHETER, PERCUTANEOUS1 report
- Sleek OTW PTA Dilatation Catheter 426-5015XCatheter, angioplasty, peripheral, transluminal1 report
Recent Sleek OTW PTA Dilatation Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951855 ↗MalfunctionMar 3, 2026Deflation Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A TRANSLUMINAL ANGIOPLASTY OF THE LEFT LOWER LIMB USING THE SLEEK OTW BALLOON. THE BALLOON WAS INFLATED TO SIX ATMOSPHERES FOR A DURATION OF THREE MINUTES. UPON COMPLETION OF THE INFLATION PERIOD, BALLOON DEFLATION WAS ATTEMPTED HOWEVER, INITIAL DEFLATION WAS UNSUCCESSFUL DESPITE MULTIPLE ATTEMPTS. THE PROCEDURE REQUIRED REPLACEMENT OF THE INFLATION DEVICE TO FACILITATE FURTHER DEFLATION EFFORTS. AFTER APPROXIMATELY TEN MINUTES OF TOTAL INFLATION TIME, THE BALLOON WAS SUCCESSFULLY DEFLATED AND REMOVED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494365 ↗MalfunctionDec 8, 2025Break; Stretched; Difficult to Open or Remove Packaging Material; Break; Stretched; Difficult to Open or Remove Packaging Material
ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE SLEEK OTW PTA CATHETER. UPON OPENING, THE SLEEVE DID NOT SEPARATE FROM THE BALLOON. HE TRIED TO PULL IT, WHICH RESULTED IN DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23738527 ↗MalfunctionAug 6, 2025Break; Stretched; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Stretched; Difficult to Open or Remove Packaging Material; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE SLEEK OTW PTA CATHETER. UPON REMOVING THE SEAL SURROUNDED THE BALLOON IT WAS UNSUCCESSFUL RESULTING IN AN EXTENSION OF THE DEVICE. THERE WERE NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724523 ↗MalfunctionJul 31, 2025Break; Packaging Problem; Break; Packaging Problem
ON (B)(6) 2025, DURING A PERIPHERAL VASCULAR ANGIOPLASTY PROCEDURE INVOLVING THE ANTERIOR TIBIAL ARTERY OF THE LOWER LIMB USING A SLEEK OTW PTA CATHETER. PRIOR TO VESSEL INSERTION, IT WAS OBSERVED THAT THE PROTECTIVE PLASTIC WAS ADHERED TO THE BALLOON, CAUSING DETACHMENT FROM THE DEVICE SHAFT AND RENDERING THE CATHETER UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22673183 ↗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 ↗MalfunctionJun 6, 2025Stretched; Difficult to Open or Remove Packaging Material; Material Deformation; Stretched; Difficult to Open or Remove Packaging Material; Material Deformation
ON (B)(6) 2024, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE SLEEK OTW PTA CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS ALLEGEDLY STRONG RESISTANCE WHILE TRYING TO REMOVE THE BALLOON COVER. IT WAS FURTHER REPORTED THAT THE BALLOON COVER ALLEGEDLY COULD NOT BE COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22160596 ↗MalfunctionMay 23, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
ON (B)(6) 2024, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING A SLEEK OTW PTA CATHETER. PRIOR TO THE PROCEDURE, THE PTA BALLOON CATHETER FELL APART AND DISASSEMBLED WHEN REMOVING THE PROTECTIVE BALLOON COVER. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22076218 ↗MalfunctionFeb 24, 2025Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, AFTER REMOVING THE BALLOON SLEEVE THE BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. IT WAS FURTHER REPORTED THAT A BREAK WAS CONFIRMED AT THE BALLOON TAPER POINT AND THE CATHETER OUTER SHAFT. IT WAS FURTHER REPORTED THAT THERE WAS EVIDENCE OF INNER STRETCHED WITHIN THE BREAK AREA. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444597 ↗MalfunctionDec 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY GOT CAUGHT ON CALCIUM AND POPPED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025717 ↗MalfunctionMar 14, 2024Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE TIBIAL FEMORAL ARTERY VIA THE COMMON FEMORAL ARTERY, THE DILATATION CATHETER WAS ALLEGEDLY STRIPPED RIGHT OFF THE SHAFT WHEN THE SCRUB TECHNICIAN REMOVED THE BALLOON FROM THE PLASTIC BALLOON HOUSING. IT WAS FURTHER REPORTED THAT THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY OF THE STERILE PACKAGING COMPONENTS. REPORTEDLY, THE DEVICE DID NOT SEPARATE INSIDE THE PATIENT AND THE BALLOON WAS NOT CAUGHT IN THE LESION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18902795 ↗MalfunctionDec 14, 2023Break; Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325320 ↗InjuryDec 13, 2023Break; Deflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material; Material Deformation; No Apparent Adverse Event; Break; Deflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material; Material Deformation; No Apparent Adverse Event
IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE BALLOON SLEEVE WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY WOULDN¿T DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 18316795 ↗MalfunctionOct 26, 2023Deflation Problem; Inflation Problem; Stretched; Material Deformation; No Apparent Adverse Event; Deflation Problem; Inflation Problem; Stretched; Material Deformation; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT FEMORAL ARTERY, THE BALLOON ALLEGEDLY WOULD NOT FULLY INFLATE UNDER NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY WOULD NOT FULLY DEFLATE WHILE ATTEMPTING TO PULL NEGATIVE PRESSURE. REPORTEDLY, THE DEVICE WAS ABLE TO BE SUCCESSFULLY REMOVED WITHOUT ANY DAMAGE TO THE VESSEL. THEN ANOTHER NEW BALLOON CATHETER WAS USED SUCCESSFULLY TO TREAT THE LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18010985 ↗
Other Clearstream Technologies Limited products
All Clearstream Technologies Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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