Sleek PTA Dilatation CatheterRecalls & reported problems across all models
Clearstream Technologies Limited · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 20 models of Sleek PTA Dilatation Catheter by Clearstream Technologies Limited in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2018 and Jan 9, 2024 — classified as 3 injuries, 85 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 PTA Dilatation Catheter problems
Device problems
- Material Rupture40
- Material Deformation37
- Failure to Advance19
- Break17
- Detachment of Device or Device Component9
- Material Twisted/Bent6
- Device Damaged Prior to Use3
- Device-Device Incompatibility3
Patient problems
- No Consequences Or Impact To Patient62
- No Clinical Signs, Symptoms or Conditions15
- No Patient Involvement9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Known Impact Or Consequence To Patient2
Sleek PTA Dilatation Catheter models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sleek PTA Dilatation Catheter 425-2522XCatheter, angioplasty, peripheral, transluminal15 reports
- Sleek PTA Dilatation Catheter 425-2022XCatheter, angioplasty, peripheral, transluminal13 reports
- Sleek PTA Dilatation Catheter 425-2012XCatheter, angioplasty, peripheral, transluminal10 reports
- Sleek PTA Dilatation Catheter 425-3004XCatheter, angioplasty, peripheral, transluminal9 reports
- Sleek PTA Dilatation Catheter 425-2515XCatheter, angioplasty, peripheral, transluminal8 reports
- Sleek PTA Dilatation Catheter 425-2015XCatheter, angioplasty, peripheral, transluminal5 reports
- Sleek PTA Dilatation Catheter 425-2512XCatheter, angioplasty, peripheral, transluminal5 reports
- Sleek PTA Dilatation Catheter 425-2504XCatheter, angioplasty, peripheral, transluminal3 reports
- Sleek PTA Dilatation Catheter 425-3022XCatheter, angioplasty, peripheral, transluminal3 reports
- Sleek PTA Dilatation Catheter 425-2008XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-2010XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-2506XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-3006XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-3012XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-4022XCatheter, angioplasty, peripheral, transluminal2 reports
- Sleek PTA Dilatation Catheter 425-2004XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek PTA Dilatation Catheter 425-3015XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek PTA Dilatation Catheter 425-3512XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek PTA Dilatation Catheter 425-3515XCatheter, angioplasty, peripheral, transluminal1 report
- Sleek PTA Dilatation Catheter 425-4004XCatheter, angioplasty, peripheral, transluminal1 report
Recent Sleek 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.
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 ↗InjuryMay 18, 2023Difficult to Remove; Component Missing; Detachment of Device or Device Component; Difficult to Remove; Component Missing; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND TO BE MISSING INSIDE THE BOX. REPORTEDLY, THE BOX WAS EMPTY. THERE WAS NO PATIENT CONTACT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16951150 ↗MalfunctionMar 21, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE INFRAPOPLITEAL LESION, THE PTA BALLOON ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16580596 ↗MalfunctionFeb 20, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE POPLITEAL ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16401975 ↗MalfunctionAug 3, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL APPROACH BELOW THE KNEE, THE SHAFT WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15155118 ↗MalfunctionMar 9, 2022Break; Break
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE DEVICE ALLEGEDLY BROKE DURING PREPARATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13704636 ↗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 ↗InjuryDec 30, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation
IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE IN WHICH THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) THE BALLOON CATHETER OF THE DEVICE WAS ALLEGEDLY NOTED TO BE CAUGHT ON TO A STENT. IT WAS FURTHER REPORTED THAT THE DISTAL TIP OF THE CATHETER GOT SEPARATED FROM THE BODY OF THE DEVICE. ANOTHER STENT WAS DEPLOYED TO HOLD THE SEPARATED SECTIONS OF THE DEVICE. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13115850 ↗MalfunctionDec 2, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12915454 ↗MalfunctionAug 24, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359343 ↗MalfunctionJun 23, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12049692 ↗InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE SHAFT OF A 3MM X 40MM X 150CM SLEEK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER SEPARATED WHILE INSIDE THE PATIENT. THE SEPARATED SEGMENT WAS REMOVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE/TARGET LESION WAS THE ARTERY OF BELOW THE KNEE. THE ACCESS SITE LOCATION WAS THE FEMORAL ARTERY. THE LESION WAS SEVERELY CALCIFIED AND TORTUOUS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. AN INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON WAS INFLATED 3 TIMES. THE PRODUCT WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11313791 ↗MalfunctionJan 19, 2021Break; Break
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11192352 ↗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 ↗MalfunctionOct 23, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10726247 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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