Savvy Long PTA Dilatation Catheter 436-2522XRecalls & reported problems
Clearstream Technologies Limited · Savvy Long PTA Dilatation Catheter 2.5mm x 220mm 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741132889), received between Feb 24, 2018 and Jul 13, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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
- Material Rupture3
- Detachment of Device or Device Component2
- Material Deformation2
- Break1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 15, 2019Material Rupture; Material Deformation; Material Rupture; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL 436-2522X PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RUPTURE AND MATERIAL DEFORMATION. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9192298 ↗MalfunctionOct 29, 2018Stretched; Detachment of Device or Device Component; Material Deformation; Stretched; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE PTA BALLOON CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE SLEEVE. REPORTEDLY, UPON REMOVAL OF THE PTA BALLOON CATHETER FROM THE BALLOON SLEEVE, KINKS AND/OR BENDS WERE ALLEGEDLY IDENTIFIED ON THE BALLOON CATHETER SHAFT, RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8016603 ↗MalfunctionFeb 24, 2018Break; Material Rupture; Break; Material Rupture
IT WAS REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED UNDER BURST RATED PRESSURE. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7294739 ↗
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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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