Atlas® Gold ATG120202Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 20 mm x 20 mm, 120 cm catheter · Class 2
All models of Atlas Gold (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741060922), received between Aug 17, 2023 and Dec 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Difficult to Remove2
- Break1
- Deflation Problem1
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Break; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Break; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, UPON WITHDRAWAL OF THE BALLOON CATHETER, THE PTA BALLOON CATHETER ALLEGEDLY HAD RESISTANCE WHEN REMOVING OUT FROM THE SHORT SHEATH. IT WAS FURTHER REPORTED THAT UPON FLUOROSCOPY, THE BALLOON MARKER WAS ALLEGEDLY FOUND INSIDE THE SHEATH AND THE BALLOON WAS SUSPECTED TO BE DISLODGED AS ONLY THE MARKER WAS SEEN ON THE CATHETER WITHOUT THE BALLOON. REPORTEDLY, THE BALLOON CATHETER, THE DISLODGED BALLOON AND THE SHORT SHEATH WERE REMOVED SUCCESSFULLY OVER THE GUIDEWIRE AND THE BALLOON WAS FOUND TO BE TRAPPED INSIDE THE SHEATH AND REMAINED INTACT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408085 ↗MalfunctionAug 17, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS COMPLETELY DETACHED FROM THE SHAFT. IT WAS FURTHER REPORTED THE DETACHED BALLOON HAD PARTIALLY OBSTRUCTED THE VESSEL. REPORTEDLY, THE BALLOON WAS REMOVED BY UNCLOGGING THE VESSEL AND THEN DEFLATING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17565901 ↗
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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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