Savvy Long PTA Dilatation Catheter 436-2515XRecalls & reported problems
Clearstream Technologies Limited · Savvy Long PTA Dilatation Catheter 2.5mm x 150mm balloon, 150cm shaft · Class 2
All models of Savvy Long PTA Dilatation Catheter (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741132827), received between Apr 6, 2018 and Jul 14, 2021 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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
- Detachment of Device or Device Component10
- Material Rupture8
- Packaging Problem5
- Material Deformation4
- Break2
- Stretched2
- Leak/Splash1
- Material Separation1
Patient problems
- No Patient Involvement8
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING DILATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165022 ↗MalfunctionMay 31, 2021Break; Break
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, AFTER REMOVAL FROM THE PACKAGING THE BALLOON WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11906675 ↗MalfunctionFeb 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11291208 ↗MalfunctionOct 21, 2020Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 436-2515X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, CATHETER STRETCHED, PACKAGING PROBLEM AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE FEMALE PATIENT IS (B)(6) AND WEIGHS (B)(6).
Patient problems: No Patient Involvement
MAUDE report 10715262 ↗MalfunctionOct 20, 2020Break; Packaging Problem; Break; Packaging Problem
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE THE PROXIMAL CATHETER NEAR THE BALLOON WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE BALLOON PROTECTIVE COVER ALLEGEDLY DIFFICULT TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10704868 ↗MalfunctionJul 16, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL 436-2515X PTA BALLOON DILATATION CATHETER WAS ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD MALE PATIENT WAS (B)(6) KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283225 ↗MalfunctionJul 15, 2020Stretched; Detachment of Device or Device Component; Material Deformation; Stretched; Detachment of Device or Device Component; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2515X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT, STRETCHED AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 10280239 ↗MalfunctionJan 13, 2020Stretched; Detachment of Device or Device Component; Packaging Problem; Stretched; Detachment of Device or Device Component; Packaging Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2515X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PACKAGING ISSUE, DETACHMENT OF DEVICE OR DEVICE COMPONENT, AND STRETCHING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9583861 ↗MalfunctionOct 12, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2515X. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9183014 ↗MalfunctionOct 31, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem
IT WAS REPORTED THAT THE BALLOON GUARD ON THE PTA BALLOON CATHETER ALLEGEDLY WAS DIFFICULT TO REMOVE. 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 8026684 ↗MalfunctionAug 24, 2018Leak/Splash; Material Rupture; Material Deformation; Leak/Splash; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR A TOTAL OCCLUSION STENOSIS TREATMENT THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE FIRST INFLATION UNDER NOMINAL PRESSURE, AND ALLEGEDLY LEAKED CONTRAST. REPORTEDLY, THE PTA DILATATION CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT, AND ANOTHER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7814918 ↗MalfunctionAug 2, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED (ATM UNKNOWN) IN THE SFA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7745269 ↗MalfunctionJul 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON REMOVAL OF THE PTA BALLOON CATHETER FROM THE PACKAGING, IT WAS ALLEGED THAT THE BALLOON WAS DETACHED FROM THE CATHETER SHAFT PRIOR TO USE, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7712714 ↗MalfunctionJun 19, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem
IT WAS REPORTED THAT THE PROTECTIVE SLEEVE OF THE BALLOON ALLEGEDLY COULD NOT BE REMOVED RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7617592 ↗MalfunctionJun 11, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON REMOVAL OF THE PTA BALLOON CATHETER FROM THE PACKAGING, IT WAS ALLEGED THAT THE BALLOON WAS DETACHED FROM THE CATHETER SHAFT PRIOR TO USE, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7589830 ↗MalfunctionMay 29, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PTA PROCEDURE, A LEAK WAS ALLEGEDLY IDENTIFIED TO THE BALLOON DURING INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7551263 ↗MalfunctionApr 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION FOR A ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY DETACHED WHILE REMOVING FROM THE PACKAGING HOOP. IT WAS FURTHER REPORTED THAT DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7455542 ↗MalfunctionApr 12, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED AT APPROXIMATELY 4 ATM IN THE RIGHT POPLITEAL ARTERY. REPORTEDLY, THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE WITH ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7427593 ↗MalfunctionApr 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON REMOVING THE PTA BALLOON CATHETER FROM THE PACKAGING THE BALLOON WAS ALLEGEDLY SEPARATED FROM THE CATHETER DELIVERY SYSTEM. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7405055 ↗
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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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