Atlas® Gold ATG120122Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 12 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
- 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 00801741060687), received between Jul 16, 2020 and Oct 21, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Break1
- Material Rupture1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE BROKEN. IT WAS FURTHER REPORTED THAT THE SHAFT WAS ALLEGEDLY BENT WHEN REMOVED FROM THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491579 ↗MalfunctionAug 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE MARKERS ON THE BALLOON WERE ALLEGEDLY NOT ON THE RIGHT POSITION, AND SO THE BALLOON WAS INFLATED AT THE WRONG POSITION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19901287 ↗MalfunctionFeb 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED WHILE INFLATED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18755530 ↗MalfunctionJul 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL ATG120122 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEVICE DISLODGED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286769 ↗
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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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