Atlas® Gold ATG120124Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® Gold PTA Dilatation Catheter 12 mm x 40 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 00801741060700), received between Jun 17, 2022 and May 23, 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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Difficult to Remove2
- Material Rupture2
- Material Frayed1
- Unraveled Material1
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.
MalfunctionMay 23, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA BILATERAL FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON BODY DETACHED FROM THE CATHETER DURING REMOVAL. REPORTEDLY, THE BALLOON BODY WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16982643 ↗MalfunctionJun 17, 2022Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL, THE BALLOON WAS ALLEGEDLY RUPTURED DURING DILATATION AROUND 5-6 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY UNABLE TO REFOLD. REPORTEDLY, THE BALLOON WAS ALLEGEDLY SEPARATED FROM THE CATHETER. THE DEVICE AND INTRODUCER SHEATH WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14727881 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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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