PRESTO ID4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00801741095009), received between Oct 3, 2017 and Sep 22, 2026 — classified as 1 death, 1 injury, 96 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (53 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Decoupling; Detachment of Device or Device Component

  On (b)(6)2026, a patient underwent an angioplasty procedure using a PTA balloon and a Presto Inflation Device. During the procedure, the three way valve became loose while under pressure. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850442 ↗
• MalfunctionSep 11, 2026Deflation Problem

  On (b)(6) 2026, a patient underwent an angioplasty procedure using a Presto inflation device and a PTA balloon. During the procedure, it was reported that the balloon could not be fully deflated and, as a result, could not be withdrawn through the sheath. The procedure was subsequently completed using another inflation device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730812 ↗
• MalfunctionApr 17, 2026Break; Decoupling; Detachment of Device or Device Component

  A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE PRESTO INFLATION DEVICE. DURING THE PROCEDURE, THE DISTAL END THAT CONNECTS TO THE BALLOON WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906960 ↗
• MalfunctionApr 17, 2026Break; Decoupling; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE PRESTO INFLATION DEVICE. DURING THE PROCEDURE, THE DISTAL END THAT CONNECTS TO THE BALLOON WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906953 ↗
• MalfunctionApr 17, 2026Break; Decoupling; Detachment of Device or Device Component

  On (b)(6) 2026, a male patient underwent a percutaneous transluminal angioplasty (PTA) procedure using a Presto Inflation Device for dilation of a dialysis fistula. During the procedure, while inflating the device, the luer lock allegedly detached and popped off, and the luer lock portion broke off. Additionally, the distal end connecting to the balloon was reported to have broken. The issue occurred during the inflation phase of the procedure. As a result of the event, medical intervention was required for the physician¿s eyes, and an eye flush was provided by DI RNs. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906950 ↗
• MalfunctionApr 17, 2026Break; Decoupling; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE PRESTO INFLATION DEVICE. DURING THE PROCEDURE, THE DISTAL END THAT CONNECTS TO THE BALLOON WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906946 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE PRESTO INFLATION DEVICE. DURING THE PROCEDURE, THE GAUGE ALLEGEDLY NOT WORKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603572 ↗
• MalfunctionMar 5, 2026Break; Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2026, A 59-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE PRESTO INFLATION DEVICE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY DID NOT INFLATE. IT WAS FURTHER REPORTED THAT THE MANOMETER WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516572 ↗
• MalfunctionOct 24, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER AND BARD PRESTO INFLATION DEVICE FOR STENOSIS OF DIALYSIS FISTULA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT A SYRINGE WAS ATTACHED TO GET THE BALLOON TO COME DOWN EVERY TIME WHEN USING IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376558 ↗
• MalfunctionOct 24, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER AND BARD PRESTO INFLATION DEVICE FOR STENOSIS OF DIALYSIS FISTULA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT A SYRINGE WAS ATTACHED TO GET THE BALLOON TO COME DOWN EVERY TIME WHEN USING IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376555 ↗
• MalfunctionJul 4, 2025Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, A PATIENT UNDERWENT ANGIOPLASTY PROCEDURE USING THE PRESTO INFLATION DEVICE AND DURING THE PROCEDURE, THE INFLATION DEVICE ALLEGEDLY DID NOT WORK AND THE DEVICE FAILED TO INFLATE THE BALLOON. IT WAS FURTHER REPORTED THAT THE PRESSURE GAUGE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402055 ↗
• MalfunctionJun 11, 2025Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE PRESTO INFLATION DEVICE AND DURING THE PROCEDURE THE SHUNT PTA 20ATM WAS UNABLE TO APPLY PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PRESTO. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181974 ↗
• MalfunctionApr 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE INFLATION DEVICE ALLEGEDLY HAD NO INCREASE IN PRESSURE ABOVE 26 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812508 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PRESSURE GAUGE ON THE INFLATION DEVICE WAS ALLEGEDLY FALLS OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686554 ↗
• MalfunctionMar 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE INFLATION DEVICE WAS ALLEGEDLY DOES NOT MOVE DURING DIFFERENTIAL PRESSURIZATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543690 ↗
• MalfunctionOct 18, 2024Break; Crack; Inflation Problem; Break; Crack; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY LEAKED WHEN EXPANDING THE BALLOON. IT WAS FURTHER REPORTED THAT THE PRESSURE WAS SLOW TO RISE FROM THE BEGINNING AND IT WAS NOT WORKING PROPERLY. REPORTEDLY, THE DEVICE ALLEGEDLY HAD A CRACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478991 ↗
• InjuryAug 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN INFLATING THE BALLOON, THE INFLATOR POINTER ALLEGEDLY VIBRATED AT A RATE OF 1 TO 2 ATM. IT WAS FURTHER REPORTED THAT THE SURGEON THOUGHT THE PRESSURE HAD NOT BEEN REACHED AND CONTINUED TO INFLATE, CAUSING THE BALLOON TO RUPTURE. FURTHERMORE, THE PATIENT'S BLOOD VESSELS WERE ALSO ALLEGEDLY RUPTURED. EVIDENTLY, THE SURGEON USED A NEW BALLOON TO STOP VESSEL BLEEDING. THE PATIENT IS REPORTED TO BE STABLE NOW.

  Patient problems: Perforation of Vessels

  MAUDE report 20044937 ↗
• MalfunctionJul 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE VIA ILIAC STENOSIS, THE PRESSURE GAUGE IN THE DEVICE WAS ALLEGEDLY NOT WORKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818961 ↗
• MalfunctionJul 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE ILIAC STENOSIS, THE PRESSURE GAUGE OF THE INFLATION DEVICE ALLEGEDLY FAILED TO WORK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749009 ↗
• MalfunctionJun 4, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD LEAKING JOINTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457504 ↗
• MalfunctionApr 29, 2024Crack; Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Crack; Inflation Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE PRESSURE WAS INCREASED BUT THE PRESSURE SUDDENLY GOT DECREASED IN THE MIDDLE OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200179 ↗
• MalfunctionDec 22, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE OUTER PACKAGE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382962 ↗
• MalfunctionNov 16, 2023Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BOX OF THE DEVICE WAS ALLEGEDLY UNSEALED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS STAINED WITH AN UNKNOWN CHEMICAL SUBSTANCE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18146496 ↗
• MalfunctionNov 16, 2023Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BOX OF THE DEVICE WAS ALLEGEDLY UNSEALED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS STAINED WITH AN UNKNOWN CHEMICAL SUBSTANCE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18146425 ↗
• MalfunctionNov 10, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT SYRINGED WAS USED TO DEFLATE THE BALLOON AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110994 ↗