Atlas® Gold ATG80122Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 12 mm x 20 mm, 80 cm catheter · Class 2
All models of Atlas Gold (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741060670), received between Feb 8, 2017 and Nov 24, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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.
Most reported problems
Device problems
- Deflation Problem2
- Device Contamination with Chemical or Other Material1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2020Deflation Problem; Material Deformation; Deflation Problem; Material Deformation
IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE BALLOON LINE ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UNABLE TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10893545 ↗MalfunctionOct 28, 2020Deflation Problem; Deflation Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL ATG80122 PTA BALLOON DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO DEFLATE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10747488 ↗MalfunctionFeb 8, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE THE STERILE PACKAGING ALLEGEDLY CONTAINED A PARTICLE INSIDE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6312654 ↗
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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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