Atlas® AT120184Recalls & reported problems
Bard Peripheral Vascular, Inc. · Atlas® PTA Balloon Dilatation Catheter 18 mm x 40 mm, 120 cm Catheter · Class 2
All models of Atlas (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741062698), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Failure to Fold1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2019Deflation Problem; Failure to Fold; Retraction Problem; Deflation Problem; Failure to Fold; Retraction Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT120184. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE, FAILURE TO FOLD, AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9194965 ↗
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- 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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