Atlas GoldRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 427
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls
- 0
We found 33 models of Atlas Gold by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 427 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Aug 13, 2026 — classified as 89 injuries, 338 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (210 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Atlas Gold problems
Device problems
- Detachment of Device or Device Component210
- Material Rupture206
- Retraction Problem80
- Difficult to Remove77
- Break71
- Deflation Problem66
- Material Frayed33
- Unraveled Material31
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- No Consequences Or Impact To Patient143
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available34
- Injury21
- Foreign Body In Patient11
- No Known Impact Or Consequence To Patient8
- Device Embedded In Tissue or Plaque7
- No Patient Involvement7
Atlas Gold models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Atlas® Gold ATG80144Catheter, angioplasty, peripheral, transluminal105 reports
- Atlas® Gold ATG80164Catheter, angioplasty, peripheral, transluminal55 reports
- Atlas® Gold ATG120144Catheter, angioplasty, peripheral, transluminal33 reports
- Atlas® Gold ATG120164CATHETER, PERCUTANEOUS27 reports
- Atlas® Gold ATG80166CATHETER, PERCUTANEOUS23 reports
- Atlas® Gold ATG80124CATHETER, PERCUTANEOUS21 reports
- Atlas® Gold ATG80184Catheter, angioplasty, peripheral, transluminal20 reports
- Atlas® Gold ATG80146CATHETER, PERCUTANEOUS18 reports
- Atlas® Gold ATG120184CATHETER, PERCUTANEOUS14 reports
- Atlas® Gold ATG80186Catheter, angioplasty, peripheral, transluminal14 reports
- Atlas® Gold ATG120146Catheter, angioplasty, peripheral, transluminal12 reports
- Atlas® Gold ATG80126Catheter, angioplasty, peripheral, transluminal8 reports
- Atlas® Gold ATG80142CATHETER, PERCUTANEOUS8 reports
- Atlas® Gold ATG120244Catheter, angioplasty, peripheral, transluminal8 reports
- Atlas® Gold ATG120204CATHETER, PERCUTANEOUS7 reports
- Atlas® Gold ATG120126CATHETER, PERCUTANEOUS6 reports
- Atlas® Gold ATG120142Catheter, angioplasty, peripheral, transluminal5 reports
- Atlas® Gold ATG120162Catheter, angioplasty, peripheral, transluminal5 reports
- Atlas® Gold ATG120186Catheter, angioplasty, peripheral, transluminal5 reports
- Atlas® Gold ATG80222Catheter, angioplasty, peripheral, transluminal5 reports
- Atlas® Gold ATG80224Catheter, angioplasty, peripheral, transluminal5 reports
- Atlas® Gold ATG120122Catheter, angioplasty, peripheral, transluminal4 reports
- Atlas® Gold ATG80122CATHETER, PERCUTANEOUS3 reports
- Atlas® Gold ATG120124CATHETER, PERCUTANEOUS2 reports
- Atlas® Gold ATG120166Catheter, angioplasty, peripheral, transluminal2 reports
- Atlas® Gold ATG120182CATHETER, PERCUTANEOUS2 reports
- Atlas® Gold ATG120202CATHETER, PERCUTANEOUS2 reports
- Atlas® Gold ATG120222Catheter, angioplasty, peripheral, transluminal2 reports
- Atlas® Gold ATG120224Catheter, angioplasty, peripheral, transluminal2 reports
- Atlas® Gold ATG80182Catheter, angioplasty, peripheral, transluminal1 report
- Atlas® Gold ATG80204CATHETER, PERCUTANEOUS1 report
- Atlas® Gold ATG80244Catheter, angioplasty, peripheral, transluminal1 report
- Atlas® Gold ATG120264Catheter, angioplasty, peripheral, transluminal1 report
Recent Atlas Gold adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Material Rupture
A patient underwent a percutaneous transluminal angioplasty procedure using the Atlas Gold balloon catheter. During the procedure, the balloon catheter was allegedly ruptured. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231616 ↗InjuryAug 5, 2026Material Rupture; Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent an angioplasty procedure using an Atlas Gold PTA balloon. During the procedure, a pinhole rupture of the balloon was noted, and the balloon subsequently degloved from the catheter shaft. As a result, the balloon separated from the shaft and remained within the patient. Furthermore, the patient was sent to ER and snared out of the pulmonary artery. The detached balloon was snared via femoral access site. The current status of the patient was unknown.
Patient problems: Foreign Body In Patient
MAUDE report 50137666 ↗MalfunctionFeb 5, 2026Material Rupture
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ATLAS GOLD BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24266038 ↗MalfunctionJan 9, 2026Break; Leak/Splash; Material Rupture
ON (B)(6) 2025, A 62-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE FOR CENTRAL VEIN STENOSIS IN FEMORAL VEIN USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY LEAKED FROM THE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017288 ↗MalfunctionDec 30, 2025Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method
ON (B)(6) 2025, A PATIENT UNDERWENT AN ESOPHAGEAL DILATATION PROCEDURE BY USING AN ATLAS GOLD BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO FULLY DEFLATE AS INTENDED. AS A RESULT, THE CATHETER HAD TO BE REMOVED WHILE PARTIALLY INFLATED, CAUSING SOME PATIENT DISTRESS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919801 ↗InjuryDec 11, 2025Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION (GASTROSCOPY) TO REMOVE THE BALLOON FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23775742 ↗MalfunctionNov 4, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. FURTHER, IT WAS UPDATED THAT THEY WERE ABLE TO FIND THE HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460633 ↗MalfunctionOct 21, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING BALLOON INFLATION, THE OPERATOR OBSERVED THAT THE BALLOON WAS LEAKING WHILE BEING INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23345599 ↗MalfunctionSep 24, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS NOT DEFLATING FULLY AND ALLEGEDLY STUCK INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130512 ↗MalfunctionSep 23, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD FOR FISTULOPLASTY INTENT STENOSIS VENOVO. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119694 ↗MalfunctionSep 23, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD FOR FISTULOPLASTY INTENT STENOSIS VENOVO. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119556 ↗MalfunctionSep 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON, THE BALLOON ALLEGEDLY BUSTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024141 ↗MalfunctionSep 9, 2025Break; Deflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Break; Deflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE INFLATED BALLOON HAD SHIFTED ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003054 ↗InjuryAug 26, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED AND DISLOCATED FROM THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions
MAUDE report 22893078 ↗MalfunctionJul 17, 2025Difficult to Remove; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Material Deformation; Material Split, Cut or Torn
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. POST THE PROCEDURE, BALLOON GOT CAUGHT AT THE TIP OF THE SHEATH AND COULD NOT BE REMOVED. REPORTEDLY, THERE WAS STRONG RESISTANCE, SO REMOVED THE SHEATH AND INSERTED A NEW SHEATH TO CONTINUE THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529222 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
- Dorado49 models · 387 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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