AtlasRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 294
- Deaths reported
- 1
- Injuries reported
- 24
- Recalls
- 0
We found 22 models of Atlas by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 294 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2017 and Sep 30, 2026 — classified as 1 death, 24 injuries, 269 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (116 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 problems
Device problems
- Material Rupture116
- Deflation Problem67
- Difficult to Remove56
- Material Frayed52
- Retraction Problem46
- Unraveled Material44
- Break32
- Peeled/Delaminated32
Patient problems
- No Clinical Signs, Symptoms or Conditions156
- No Consequences Or Impact To Patient115
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- No Known Impact Or Consequence To Patient6
- Injury3
- Needle Stick/Puncture3
- Hematoma2
- Hemorrhage/Blood Loss/Bleeding2
Atlas models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Atlas® AT75144CATHETER, PERCUTANEOUS1 death93 reports
- Atlas® AT75164CATHETER, PERCUTANEOUS36 reports
- Atlas® AT75186Catheter, angioplasty, peripheral, transluminal35 reports
- Atlas® AT75124Catheter, angioplasty, peripheral, transluminal25 reports
- Atlas® AT120144Catheter, angioplasty, peripheral, transluminal16 reports
- Atlas® AT120124CATHETER, PERCUTANEOUS14 reports
- Atlas® AT75166Catheter, angioplasty, peripheral, transluminal13 reports
- Atlas® AT120164Catheter, angioplasty, peripheral, transluminal13 reports
- Atlas® AT75184CATHETER, PERCUTANEOUS10 reports
- Atlas® AT75126CATHETER, PERCUTANEOUS9 reports
- Atlas® AT75204CATHETER, PERCUTANEOUS7 reports
- Atlas® AT75146CATHETER, PERCUTANEOUS6 reports
- Atlas® AT120204CATHETER, PERCUTANEOUS5 reports
- Atlas® AT75142CATHETER, PERCUTANEOUS2 reports
- Atlas® AT75162CATHETER, PERCUTANEOUS2 reports
- Atlas® AT75244Catheter, angioplasty, peripheral, transluminal2 reports
- Atlas® AT75202Catheter, angioplasty, peripheral, transluminal1 report
- Atlas® AT75222CATHETER, PERCUTANEOUS1 report
- Atlas® AT75224CATHETER, PERCUTANEOUS1 report
- Atlas® AT75264Catheter, angioplasty, peripheral, transluminal1 report
- Atlas® AT120162CATHETER, PERCUTANEOUS1 report
- Atlas® AT120184CATHETER, PERCUTANEOUS1 report
Recent Atlas adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Deflation Problem
On (b)(6)2026, a (b)(6) male patient underwent an angioplasty procedure using the PTA balloon. During the procedure, the balloon allegedly failed to deflate following inflation. To resolve the issue, the balloon was punctured using a transseptal needle, after which it successfully deflated and was withdrawn through the sheath. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942965 ↗InjurySep 22, 2026Deflation Problem; Difficult to Remove
On (b)(6) 2026, a patient underwent an angioplasty procedure using the Atlas PTA balloon. During the procedure, the balloon failed to deflate within the subclavian vein and could not be withdrawn through the sheath. To facilitate removal, the balloon was punctured and fluid was aspirated using multiple syringes until the balloon volume was sufficiently reduced. The balloon, sheath, and guidewire were then removed together. The patient experienced collateral bleeding and developed a hematoma; manual pressure was applied to achieve hemostasis. The patient was monitored for approximately 8 hours and was subsequently discharged. The procedure was successfully completed using a replacement balloon. At follow up, the patient was reported to be doing well.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50851661 ↗MalfunctionAug 7, 2026Deflation Problem; Difficult to Remove
A patient underwent a percutaneous transluminal angioplasty (PTA) procedure using an Atlas balloon catheter. During the procedure, it was reported that the balloon failed to deflate within the subclavian vein. It was further reported that the HCP was unable to withdraw the balloon through the sheath. To facilitate safe removal, the balloon was cut at the tip and subsequently retrieved. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169285 ↗MalfunctionJul 30, 2026Break; Material Deformation
On (b)(6) 2026, a patient was prepped for a percutaneous transluminal angioplasty (PTA) procedure using an Atlas balloon catheter. Prior to the procedure, it was noted that the balloon catheter had become disconnected from the sheath. It was further reported that the balloon had partially detached from the device while remaining partially attached. it was broken before they used it. The procedure was subsequently completed using an alternative device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078385 ↗MalfunctionJun 22, 2026Break; Inflation Problem; Unraveled Material
ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO INFLATE. THEREFORE, UNRAVELING AND A PARTIAL BREAK WAS DETECTED AT LOCATION OF THE WATER LEAKING FROM THE PROXIMAL END OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25574545 ↗MalfunctionJun 3, 2026Deflation Problem; Inflation Problem; Difficult to Remove; Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO INFLATE AND DEFLATE. IT WAS FURTHER REPORTED THAT THERE IS A DIFFICULTY IN RETRACTING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25371581 ↗MalfunctionMar 30, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24724977 ↗MalfunctionFeb 17, 2026Deflation Problem
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361587 ↗MalfunctionFeb 5, 2026Deflation Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ATLAS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265534 ↗MalfunctionJan 29, 2026Deflation Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ATLAS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207463 ↗MalfunctionJan 13, 2026Difficult to Remove; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. REPORTEDLY, WHILE TRYING TO REMOVE THE PRODUCT, THE SHEATH HAD TO BE REMOVED AS WELL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050572 ↗MalfunctionJan 5, 2026Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT DILATED BALLOON BECAME STUCK ON THE VASCULAR SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON DILATATION CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956214 ↗MalfunctionDec 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO DEFLATE. THERE WERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815236 ↗MalfunctionDec 12, 2025Deflation Problem; Deflation Problem
A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY UNABLE TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23786367 ↗MalfunctionNov 6, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Deflation Problem; Entrapment of Device; Difficult to Remove
ON (B)(6) 2025, A (B)(6) MALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON VIA LEFT UPPER ARM GRAFT TO THE ACCESS SITE OF SUPERIOR VENA CAVA, BRACHIOCEPHALIC, AND AXILLARY VEINS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY WOULD NOT DEFLATE AND FURTHER IT GOT STUCK IN A CENTRALLY LOCATED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483409 ↗
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
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 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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