Biotronik Passeo-35 HP 12/40/75Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525781617), received between Apr 20, 2016 and Jul 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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
- Deflation Problem1
- Difficult to Insert1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2020Deflation Problem; Deflation Problem
AN 8F 45CM ARROW SHEATH WAS USED TO INTRODUCE THE BALLOON. A COOK ROADRUNNER 035 SYSTEM 180CM WIRE WAS USED TO GUIDE THE BALLOON TO THE LESION. A PASSEO-35 4/60/90 BALLOON WAS USED TO PRE-DILATE THE LESION IN THE SUBCLAVIAN VEIN. AFTER PRE-DILATION, THE PASSEO-35HP 12/40/75 BALLOON WAS INTRODUCED TO FURTHER DILATE THE VESSEL. BALLOON WAS INFLATED THROUGH THE 8F 45CM ARROW SHEATH AND DEFLATED AFTER 2 MINUTES AT 18ATM PRESSURE. WHEN BALLOON WAS ABOUT TO BE REMOVED FROM THE SHEATH, PHYSICIAN EXPERIENCED DIFFICULTY IN PULLING THE BALLOON OUT, DESPITE USING FORCE. AFTER NUMEROUS ATTEMPTS, PHYSICIAN REMOVED THE SHEATH ALONG WITH THE BALLOON AND REVEALED THE BALLOON WAS STUCK AT THE DISTAL OPENING OF THE SHEATH AS BALLOON DID NOT DEFLATE AND REWRAP PROPERLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10258894 ↗MalfunctionApr 20, 2016Difficult to Insert; Difficult to Insert
THE PASSEO-35 HP 12*40*75 CATHETER CANNOT RE-ENTER INTO THE 8FR SHEATH AFTER 1ST INFLATION. PHYSICIAN HAD NO CHOICE BUT TO CHANGE TO 9FR SHEATH FOR THE SECOND TIME ENTRY BY USING THE SAME BALLOON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5588710 ↗
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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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