Atlas® AT75162Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® PTA Balloon Dilatation Catheter 16 mm x 20 mm, 75 cm Catheter · Class 2
All models of Atlas (22)
Data updated Oct 16, 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 00801741062452), received between Nov 21, 2017 and Dec 13, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Material Frayed1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2017Material Frayed; Material Frayed
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE OUTER SHEATH OF THE PTA BALLOON ALLEGEDLY FRAYED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7115420 ↗MalfunctionNov 21, 2017Break
PT UNDERWENT FISTULOGRAM WITH BALLOON ANGIOPLASTY OF THE BASILIC VEIN, RIGHT SUBCLAVIAN VEIN AND RIGHT BRACHIOCEPHALIC VEIN. DURING BALLOONING OF A CONSTRICTED AREA, WHEN BALLOON WAS REMOVED FROM THE SHEATH, THEY NOTICED THE OUTER LAYER OF THE BALLOON WAS SHREDDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7049116 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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