Atlas® Gold ATG80244Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 24 mm x 40 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741061011), received between Jul 23, 2018 and Jul 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Material Rupture1
- Retraction Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY TO DILATE A RESTENOSED 24MM WALL STENT IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY AND THEN INVERTED ITSELF. REPORTEDLY, THE BALLOON COULD NOT BE RETRACTED THROUGH THE VEIN AND INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL FOR A CUT DOWN TO REMOVE THE DETACHED BALLOON. THERE WAS NO KNOWN IMPACT OF CONSEQUENCE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7712773 ↗
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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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