ULTRASCORERecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 61 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 287
- Deaths reported
- 1
- Injuries reported
- 84
- Recalls
- 0
We found 61 models of ULTRASCORE by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 287 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2018 and Sep 8, 2026 — classified as 1 death, 84 injuries, 202 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (87 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 ULTRASCORE problems
Device problems
- Material Rupture87
- Adverse Event Without Identified Device or Use Problem83
- Difficult to Remove67
- Device-Device Incompatibility49
- Material Deformation31
- Break30
- Detachment of Device or Device Component25
- Device Dislodged or Dislocated22
Patient problems
- No Clinical Signs, Symptoms or Conditions191
- Vascular Dissection57
- Stenosis25
- No Consequences Or Impact To Patient11
- Restenosis11
- Occlusion6
- Injury3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
ULTRASCORE models
61 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTRASCORE US14150530Catheter, percutaneous, cutting/scoring15 reports
- ULTRASCORE US14150515Catheter, percutaneous, cutting/scoring14 reports
- ULTRASCORE US14150615Catheter, percutaneous, cutting/scoring14 reports
- ULTRASCORE US3513058Catheter, percutaneous, cutting/scoring14 reports
- ULTRASCORE US3513054Catheter, percutaneous, cutting/scoring12 reports
- ULTRASCORE US35130515Catheter, percutaneous, cutting/scoring12 reports
- ULTRASCORE US14150430Catheter, percutaneous, cutting/scoring11 reports
- ULTRASCORE US14150610Catheter, percutaneous, cutting/scoring11 reports
- ULTRASCORE US1415064Catheter, percutaneous, cutting/scoring10 reports
- ULTRASCORE US14150630Catheter, percutaneous, cutting/scoring10 reports
- ULTRASCORE US35130512Catheter, percutaneous, cutting/scoring9 reports
- ULTRASCORE US1415044Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US1415054Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US35130510Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US35130520Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US35130610Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US35130630Catheter, percutaneous, cutting/scoring8 reports
- ULTRASCORE US14150330Catheter, percutaneous, cutting/scoring7 reports
- ULTRASCORE US14150510Catheter, percutaneous, cutting/scoring7 reports
- ULTRASCORE US141502H30Catheter, percutaneous, cutting/scoring6 reports
- ULTRASCORE US14150415Catheter, percutaneous, cutting/scoring6 reports
- ULTRASCORE US1415074Catheter, percutaneous, cutting/scoring6 reports
- ULTRASCORE US14150320Catheter, percutaneous, cutting/scoring5 reports
- ULTRASCORE US3513068Catheter, percutaneous, cutting/scoring5 reports
- ULTRASCORE US14150310Catheter, percutaneous, cutting/scoring4 reports
- ULTRASCORE US35130615Catheter, percutaneous, cutting/scoring4 reports
- ULTRASCORE US141502H15Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US14150315Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US14150410Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US35130412Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US35130530Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US3513064Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US35130612Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US35130620Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US3513074Catheter, percutaneous, cutting/scoring3 reports
- ULTRASCORE US14150220Catheter, percutaneous, cutting/scoring2 reports
- ULTRASCORE US141502H20Catheter, percutaneous, cutting/scoring2 reports
- ULTRASCORE US3513044Catheter, percutaneous, cutting/scoring2 reports
- ULTRASCORE US3513078Catheter, percutaneous, cutting/scoring2 reports
- ULTRASCORE US14150210Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US14150230Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141502H4Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141502H8Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US1415038Catheter, percutaneous, cutting/scoring1 death1 report
- ULTRASCORE US14150312Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141503H4Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141503H10Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141503H20Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US141503H30Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US14150420Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US1415052Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US1415058Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US14150512Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US3513048Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US35130410Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US35130415Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US35130420Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US35130710Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US3513082Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US3513088Catheter, percutaneous, cutting/scoring1 report
- ULTRASCORE US35130812Catheter, percutaneous, cutting/scoring1 report
Recent ULTRASCORE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Difficult to Remove
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty procedure using an UltraScore 014 balloon catheter. During the procedure, it was reported that the balloon catheter could not be removed. The procedure was completed as intended. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667738 ↗MalfunctionJul 27, 2026Material Rupture
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure using the UltraScore 035 balloon catheter. During the procedure, the balloon catheter allegedly ruptured. The procedure was completed using another balloon. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021295 ↗MalfunctionMay 14, 2026Break; Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS DILATED IN A CALCIFIED SUPERFICIAL FEMORAL ARTERY AND THE WIRE ALLEGEDLY BROKEN. THE BALLOON COULD ONLY BE REMOVED TOGETHER WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25171046 ↗MalfunctionMay 11, 2026Break; Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DUAL-WIRE BALLOON WAS INFLATED IN THE BODY, IT WAS RETRIEVED, AND THE WIRE CONNECTION WAS FRACTURED. FURTHERMORE, THERE WAS DIFFICULT IN RETRACTING THE DEVICE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134012 ↗MalfunctionApr 2, 2026Difficult to Remove; Device-Device Incompatibility
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY STUCK WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764304 ↗MalfunctionFeb 9, 2026Break; Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE WIRE ALLEGEDLY DETACHED FROM BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290363 ↗MalfunctionFeb 2, 2026Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE VIA THE SUPERFICIAL FEMORAL ARTERY USING THE ULTRASCORE 014 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER COULD NOT BE REINSERTED AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232631 ↗MalfunctionJan 30, 2026Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO REMOVE FORM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219173 ↗MalfunctionJan 8, 2026Break
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON GUIDEWIRE ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24000418 ↗MalfunctionJan 6, 2026Difficult to Remove; Device-Device Incompatibility
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER VIA FEMORAL APPROACH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23971228 ↗MalfunctionOct 6, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER. DURING THE PROCEDURE IN THE LEFT FEMORAL ARTERY, THE BALLOON CONTRAST WAS ALLEGEDLY LEAKING AND A PINHOLE RUPTURE WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT THERE IS A SLIGHT DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23219100 ↗MalfunctionSep 9, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON BECAME STUCK WITH THE GUIDEWIRE DURING REMOVAL. AND THERE WAS STRONG RESISTANCE FELT AND WAS UNABLE TO REMOVE IT. AFTER THREE OR FOUR ATTEMPTS, CUSTOMER WAS FORCED TO REMOVE THE ENTIRE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001689 ↗MalfunctionSep 8, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990015 ↗MalfunctionSep 2, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE IN A CASE OF IPSILATERAL ANTEGRADE BK USING AN ULTRASCORE 014. DURING PROCEDURE, ATTEMPTS WERE MADE TO EXPAND THE POP STENOSIS AND THEN REMOVE IT, BUT IT DID NOT COME OUT WHEN THE BALLOON'S TIP MARKER APPROACHED THE ENTRANCE OF THE SHEATH, SO IT WAS PUSHED BACK INTO THE BODY AGAIN, THERE WAS RESISTANCE AND IT WAS DIFFICULT TO PASS. INFLATION AND DEFLATION WERE PERFORMED, AND ATTEMPTS WERE MADE TO REMOVE IT AGAIN, BUT IT DID NOT COME OUT, SO THE SHEATH WAS REMOVED AND TAKEN OUT OF THE BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936372 ↗MalfunctionAug 25, 2025Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER. DURING THE PROCEDURE AFTER PASSING THE GUIDEWIRE IT WAS ATTEMPTED TO BE REMOVED, BUT IT BECAME STUCK WITH THE GUIDEWIRE AND WAS REMOVED TOGETHER WITH IT. IT WAS DELIVERED IN ORDER TO BE USED AGAIN, BUT THERE WAS STRONG RESISTANCE UPON DELIVERY AND ALSO UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882005 ↗
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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