Passeo-14 2/220/150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130433861), received between Dec 7, 2022 and Jan 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID TIBIAL ARTERY. THE AFFECTED DEVICE WAS INTRODUCED, AND A HUB LEAKAGE WAS DETECTED. DURING THE TECHNICAL INVESTIGATION A BALLOON PINHOLE WAS OBSERVED. THE PINHOLE DID NOT OCCUR DUE TO THE REPORTED COMPLAINT EVENT. THE HUB LEAKAGE WAS DETECTED BY THE PHYSICIAN, BUT THE PINHOLE REMAINED UNDETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535660 ↗
• MalfunctionJan 3, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID TIBIAL ARTERY. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY AND ADVANCED TO THE AREA OF INTEREST. ONCE POSITIONED, THE BALLOON WAS INFLATED WITH A MAXIMUM PRESSURE OF 8 ATM. THEREAFTER, THE 0.014 INCH GUIDEWIRE WAS REMOVED. THE PHYSICIAN TOOK A 3CC SYRINGE WITH 0.5 ML CONTRAST MEDIUM AND 2 ML SALINE AND INJECTED THE SOLUTION THROUGH THE GUIDEWIRE PORT DURING WHICH THE SOLUTION WAS SEEN TO EMERGE FROM THE BALLOON PORT OF THE AFFECTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437194 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT IN A DISTAL TIBIAL ARTERY. THE BALLOON RUPTURED. THE PHYSICIAN DID NOT TAKE PAST RBP BUT DID INFLATE PRIOR TO ATHERECTOMY TO MAKE WAY FOR DEVICE. HE IS PRE-DILATING AND INFLATES FAST STRAIGHT TO NOMINAL AND/OR BEYOND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020171 ↗
• MalfunctionDec 7, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS INTRODUCED INTO PATIENTS BODY AND INFLATED. DURING SECOND INFLATION AFTER THREE MINUTES AT NOMINAL PRESSURE THE BALLOON RUPTURED. ANOTHER BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931449 ↗