Atlas® Gold ATG120166Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 16 mm x 60 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741060847), received between Oct 11, 2021 and Aug 26, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Embolism/Embolus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED AND DISLOCATED FROM THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions
MAUDE report 22893078 ↗MalfunctionOct 11, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12603121 ↗
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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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