Biotronik Passeo-35 HP 8/40/75Recalls & reported problems
Creagh Medical Limited · Class 2
All models of Biotronik Passeo-35 HP (9)
Data updated Oct 18, 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 05391525781563), received between Jul 11, 2017 and Nov 14, 2022 — classified as 1 injury, 2 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
Device problems
- Material Rupture3
- Detachment of Device or Device Component1
- Material Puncture/Hole1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Rupture1
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
DURING THE PROCEDURE ON 9/27/2022 IN THE BCF VESSEL, THE BALLOON BURST DURING THE SECOND INFLATION ATTEMPT BETWEEN 25-27 ATM. THE BALLOON BURST INSIDE THE PATIENT. NO DEVICE FRAGMENTS REMAINED IN THE BODY AND THE PATIENT WAS LATER DISCHARGED HOME WITHOUT ADDITIONAL MEDICAL INTERVENTION OR HARM. 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 25%). THERE WAS NO IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15788672 ↗InjurySep 10, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
PATIENT WAS RECEIVING A FISTULOGRAM WITH INTERVENTION. A BALLOON WAS INTRODUCED IN THE FISTULA AND BURST DURING INFLATION. ON SYSTEM REMOVAL, IT WAS NOTED THAT THE MARKER BAND AT THE BALLOON TIP HAD BROKEN OFF INTO THE TISSUE. TIP WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 7860670 ↗MalfunctionJul 11, 2017Material Rupture; Material Rupture
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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