Biotronik Passeo-35 HP 10/40/75Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05391525781600), received between Apr 20, 2016 and Mar 18, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Fracture; Fracture

  THE BALLOON CATHETER WAS USED FOR A TREATMENT OF A LESION WITH 70% STENOSIS IN THE MILD LEFT BRACHIOCEPHALIC FISTULA (BCF). THE BALLOON WAS PREPARED AS PER IFU. THE BALLOON WAS INFLATED AT 18 ATM AND OPERATED AS EXPECTED DURING THE FIRST INFLATION. A SECOND INFLATION AT 18 ATM WAS PERFORMED AND THE BALLOON BURST BEFORE THE RATED BURST PRESSURE WAS REACHED. THERE WAS NO CALCIFICATION AND NOT TORTUOUS ANATOMY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926895 ↗
• InjuryJan 10, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  THE 10MM HIGH PRESSURE BALLOON BURST WHILE INFLATING AT THE RATED BURST PRESSURE, 20ATM. THE BALLOON FRAGMENT WAS STUCK IN THE VEIN FIBROTIC TISSUE AND WAS UNABLE TO BE REMOVED. IT WAS ALSO NOTED THAT A PART OF THE BALLOON WAS ALSO STUCK AT THE TIP OF THE GUIDE SHEATH. SOME FORCE WAS APPLIED TO REMOVE THE BALLOON CATHETER AND GUIDE SHEATH FROM THE VEIN. PARTS OF THE BALLOON WERE ALSO BROKEN AND STUCK IN THE PATIENT ANATOMY NEAR THE PUNCTURE SITE. A VENOUS CUT DOWN WAS PREFORMED TO REMOVE THE REMAINING BALLOON. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT ANATOMY. THE REPORTED ISSUE RESULTED IN PROLONGED PATIENT HOSPITALIZATION. A PERMANENT CATHETER WAS ALSO INSERTED INTO THE PATIENT FOR DIALYSIS DUE TO THE TRAUMA SUSTAINED TO THE FISTULA BRACHIAL CEPHALIC VEIN. IT WAS NOTED THE LESION LOCATION WAS LOCATED DISTALLY. THE APPROXIMATE VESSEL DIAMETER WAS REPORTED TO BE 10MM WITH A STENOSIS DEGREE OF 70% AND LESION LENGTH OF 60MM. THE VESSEL HAD MILD TORTUOSITY AND SEVERE CALCIFICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16133573 ↗
• MalfunctionSep 30, 2022Failure to Deflate; Failure to Deflate

  ON 08SEP2022, MANUFACTURER BECAME AWARE OF THE EVENT, DESCRIBED AS "BALLOON DID NOT DEFLATE PROPERLY". PROCEDURE WAS PERFORMED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510236 ↗
• MalfunctionMay 25, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  DURING INFLATION THE BALLOON BURST OCCURED LONGITUDINALLY AT 16ATM. THE BALLOON WAS SUCCESSFULLY RETRIEVED WITHOUT COMPLICATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879574 ↗
• InjuryAug 2, 2017Material Rupture; Material Rupture

  DURING THE TREATMENT OF A TIGHT LESION OF THE CENTRAL VEIN, THE BALLOON RUPTURED RADIALLY INTO TWO PARTS. WHILE WITHDRAWING THE TIP DISLODGED AND STUCK AT THE NECK OF THE STENOSIS AND COULD NOT BE REMOVED. AFTER 10 MINUTES THROMBUS DEVELOPED AT THE LESION. VASCULAR SURGEON ASSESSED THAT MIGRATION OF THE DEVICE WAS NOT POSSIBLE. PATIENT BEING MONITORED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6760939 ↗
• MalfunctionJun 22, 2017Difficult to Remove; Difficult to Remove

  PROCEDURE WAS SMOOTH UNTIL DEFLATION AND WITHDRAWAL FROM SHEATH. BALLOON WINGS DID NOT REWRAP WELL AND GOT STUCK AT THE SHEATH. DOCTOR REQUESTED PRODUCT INVESTIGATION AND REPORT. PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6661125 ↗
• MalfunctionApr 20, 2016Inflation Problem; Inflation Problem

  THE PASSEO-35 HP 10/40/75 PRODUCT LEAKS DURING INFLATION TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5589985 ↗