Savvy Long PTA Dilatation CatheterRecalls & reported problems across all models
Clearstream Technologies Limited · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 19 models of Savvy Long PTA Dilatation Catheter by Clearstream Technologies Limited in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2018 and Mar 11, 2022 — classified as 1 injury, 54 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (30 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
Most reported Savvy Long PTA Dilatation Catheter problems
Device problems
- Material Rupture30
- Detachment of Device or Device Component23
- Material Deformation15
- Break9
- Packaging Problem8
- Retraction Problem5
- Stretched4
- Device-Device Incompatibility3
Patient problems
- No Consequences Or Impact To Patient30
- No Patient Involvement15
- No Clinical Signs, Symptoms or Conditions10
Savvy Long PTA Dilatation Catheter models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Savvy Long PTA Dilatation Catheter 436-2515XCatheter, angioplasty, peripheral, transluminal19 reports
- Savvy Long PTA Dilatation Catheter 436-2012XCatheter, angioplasty, peripheral, transluminal4 reports
- Savvy Long PTA Dilatation Catheter 436-2522LCatheter, angioplasty, peripheral, transluminal4 reports
- Savvy Long PTA Dilatation Catheter 436-2522XCatheter, angioplasty, peripheral, transluminal4 reports
- Savvy Long PTA Dilatation Catheter 436-2512XCatheter, angioplasty, peripheral, transluminal3 reports
- Savvy Long PTA Dilatation Catheter 436-2015XCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-2022LCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-2512LCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-2515LCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-2522SCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-3015XCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-4015XCatheter, angioplasty, peripheral, transluminal2 reports
- Savvy Long PTA Dilatation Catheter 436-3015LCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-3022XCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-3515XCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-4015LCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-4022XCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-5015LCatheter, angioplasty, peripheral, transluminal1 report
- Savvy Long PTA Dilatation Catheter 436-5015XCatheter, angioplasty, peripheral, transluminal1 report
Recent Savvy Long 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.
MalfunctionMar 11, 2022Material Rupture; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Material Rupture; Difficult to Advance; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LOWER EXTREMITY ARTERIOSCLEROSIS VIA A MODERATELY CALCIFIED LESION TO TREAT THE FEMORAL POPLITEAL SEGMENT AND THE SUPERFICIAL SEGMENT OF THE FEMUR, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REACH THE LESION AND IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 12 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13730156 ↗MalfunctionDec 9, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, THE BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE BALLOON WAS REMOVED OFF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965971 ↗MalfunctionOct 8, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE FEMORAL POPLITEAL ARTERY, THE DEVICE ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12595660 ↗MalfunctionSep 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PREPARATION FOR ANGIOPLASTY PROCEDURE, THE TIP OF THE PTA BALLOON WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12497505 ↗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 ↗MalfunctionJul 13, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
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 12157282 ↗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 25, 2021Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A DEVICE-DEVICE INCOMPATIBILITY. IT WAS FURTHER REPORTED THAT, THE DEVICE ALLEGEDLY RETRACTION FAILURE. REPORTEDLY, BALLOON AND GUIDEWIRE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11376910 ↗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 Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2512X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION HAD PATIENT INVOLVEMENT HOWEVER THERE WERE NO PATIENT CONSEQUENCES. THE MALE PATIENT WAS REPORTED TO BE (B)(6) AND WEIGHED (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283466 ↗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, 2020Device Markings/Labelling Problem; Device Dislodged or Dislocated; Device Markings/Labelling Problem; Device Dislodged or Dislocated
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 436-2512X OTW PTA CATHETER ALLEGEDLY EXPERIENCED DEVICE DISLOCATION AND DEVICE MARKING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD MALE IS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10280769 ↗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 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page