Passeo-35 6/40/80Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640119558189), received between Sep 2, 2020 and Oct 25, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF AN ARTERIOVENOUS FISTULA. THE DEVICE WAS ADVANCED TO THE LESION AND WHEN STARTING TO INFLATE THE BALLOON UP TO 12 ATM, WHEN BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004680 ↗MalfunctionMay 20, 2021Activation Failure; Activation Failure
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A ARTERIOVENOUS FISTULA STENOSIS. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860320 ↗InjurySep 2, 2020Material Rupture; Material Rupture
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF AN ARTERIOVENOUS FISTULA DYSFUNCTION. AFTER POSITIONING THE BALLOON WAS INFLATED UP TO 16 ATM. DURING ATTEMPT TO INFLATE A 2ND TIME WITH SAME PRESSURE, THE BALLOON RUPTURED AND COULD NOT BE WITHDRAWN AND WAS RETRIEVED WITH AN INCISION.
Patient problems: Injury
MAUDE report 10484028 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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