Biotronik Passeo-35 HP 8/80/75Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391525781587), received between Nov 14, 2022 and Nov 14, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A COMPETITOR 8MM BALLOON. IT WAS NOTED THE BALLOON WAS USED TO TREAT AN AREA NOT AT THE ACTUALLY ARTERIOVENOUS FISTULA (AVF) ANASTOMOTIC SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789008 ↗
• MalfunctionNov 14, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  DURING TREATMENT OF A BRACHIOCEPHALIC FISTULA (BCF), THE BALLOON BURST AT 21 ATM DURING FIRST INFLATION. THIS WAS THE SECOND BALLOON WHICH BURST DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THE BALLOON WAS PREPPED PER INDICATIONS FOR USE. THE REPORTED ISSUE OCCURRED IN A VENOPLASTY PROCEDURE. THE TARGET VESSEL HAD MODERATION CALCIFICATION (APPROXIMATELY 30%). THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788237 ↗
• MalfunctionNov 14, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  DURING TREATMENT OF A BRACHIOCEPHALIC FISTULA (BCF), THE BALLOON BURST AT 21 ATM DURING FIRST INFLATION. MID BRACHIOCEPHALIC FISTULA, MODERATE CALCIFICATION, NO PRODUCT REMAINED IN THE PATIENT. THERE WAS NO IMPACT TO PATIENT OUTCOME. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED HOME. ADDITIONAL INFORMATION RECEIVED INDICATED THE BALLOON WAS PREPPED PER INDICATIONS FOR USE. THE REPORTED ISSUE OCCURRED IN A VENOPLASTY PROCEDURE. THE TARGET VESSEL HAD MODERATION CALCIFICATION (APPROXIMATELY 30%). THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788230 ↗