Passeo-35 XeoRecalls & reported problems across all models
Biotronik AG · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls
- 0
We found 17 models of Passeo-35 Xeo by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2023 and Apr 16, 2026 — classified as 1 death, 5 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Passeo-35 Xeo problems
Device problems
- Material Rupture13
- Fracture4
- Difficult to Remove3
- Failure to Advance2
- Inflation Problem2
- Material Deformation2
- Activation Problem1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Foreign Body In Patient2
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Vascular Dissection1
Passeo-35 Xeo models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Passeo-35 Xeo 8/40/90Catheter, angioplasty, peripheral, transluminal3 reports
- Passeo-35 Xeo 7/40/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-35 Xeo 6/40/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-35 Xeo 7/20/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 4/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 5/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 6/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 9/40/90Catheter, angioplasty, peripheral, transluminal1 death1 report
- Passeo-35 Xeo 6/80/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 5/100/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 6/60/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 8/60/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 7/80/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 5/100/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 6/150/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 5/200/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 Xeo 5/250/130Catheter, angioplasty, peripheral, transluminal1 report
Recent Passeo-35 Xeo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathApr 16, 2026Fracture; Material Rupture
DURING A FISTULAGRAM, AN IN-STENT RESTENOSIS WAS FOUND. THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS USED FOR THE TREATMENT BUT WHILE INFLATING, THE BALLOON RUPTURED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BALLOON, BUT THEY WERE UNSUCCESSFUL, AND THE BALLOON SEPARATED INTO 2 PIECES, WITH A PORTION CONTINUING TO MIGRATE FURTHER THE PATIENT. JUST ABOUT 1/4 OF THE BALLOON WAS ABLE TO BE REMOVED. THE PATIENT WAS TRANSPORTED FROM THE OUTPATIENT CENTER TO THE HOSPITAL FOR FURTHER EVALUATION AND INTERVENTION. THE NEXT DAY, WHEN THE HOSPITAL DECIDED TO PERFORM ANOTHER PROCEDURE TO REMOVE THE REMAINING PARTS OF THE DEVICE, THE PATIENT PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 24893426 ↗MalfunctionDec 22, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THE PASSEO-35 XEO PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE ILIAC ARTERY. THE DEVICE COULD NOT PASS THE LESION. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863037 ↗InjuryNov 10, 2025Malposition of Device; Activation Problem; Malposition of Device; Activation Problem
A PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED VENOUS STENOSIS IN AN ARTERIOVENOUS FISTULA. PRE-DILATATION WITH 2 BALLOONS (4/20 MM, 5/20 MM) WAS INEFFECTIVE. THE PULSAR-18 T3 WAS THEN IMPLANTED VIA A 4F SHEATH, BUT AFTER ONE-THIRD DEPLOYMENT, THE STENT MIGRATED INTO THE DILATED VENOUS SEGMENT, LEAVING TWO-THIRDS UNDEPLOYED.
Patient problems: Foreign Body In Patient
MAUDE report 23508243 ↗InjuryOct 1, 2025Fracture; Material Rupture; Fracture; Material Rupture
A PASSEO-35 XEO WAS SELECTED FOR TREATMENT OF THE LEFT COMMON ILIAC ARTERY. THE BALLOON RUPTURED DURING DEFLATION TO REMOVE THE BALLOON FROM GUIDEWIRE. THE FIRST PART OF THE BALLOON WAS EXTRACTED THROUGH THE GUIDEWIRE, BUT THE OTHER PART REMAINED IN THE PATIENT. THIS REQUIRED AN EXTENSIVE SURGICAL APPROACH TO EXTRACT THE MISSING PART AND THE USE OF A SURGICAL PATCH.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23189248 ↗InjuryAug 7, 2025Fracture; Material Rupture; Fracture; Material Rupture
A PASSEO-35 XEO WAS SELECTED FOR A VENOUS RECANALIZATION PROCEDURE. THE DEVICE RUPTURED, LEAVING PARTS OF IT (INCLUDING THE TIP, A SECTION OF THE CATHETER, AND THE BALLOON) INSIDE THE PATIENT'S VEIN. A SECOND PUNCTURE WAS NECESSARY TO RETRIEVE THE REMAINING PART, WHICH EXTENDED THE DURATION OF THE PROCEDURE AND THE PATIENT'S ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735208 ↗MalfunctionJun 4, 2025Material Rupture; Material Rupture
THE PAASSEO-35 XEO PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT IN A MILDLY CALCIFIED LESION. WHEN THE BALLOON WAS INFLATED, IT RUPTURED EVEN WHEN IT WAS DEFLATED, SLOWER THAN THE NORMAL RATE. IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED AND THAT THE INTERVENTION WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140978 ↗MalfunctionMar 27, 2025Material Rupture; Material Rupture
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF MILDLY CALCIFIED LESION IN THE FISTULA. THE PASSEO-35 XEO WAS NOT EVEN INFLATED AT NOMINAL PRESSURE YET AND THE BALLOON FRACTURED RADIALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21709211 ↗MalfunctionMar 25, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE BALLOON WAS DELIVERED TO THE LESION BUT COULD NOT PASS THE LESION. THE DEVICE WAS WITHDRAWN AND THE DELIVERY SHAFT WAS FOUND KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692848 ↗MalfunctionMar 25, 2025Material Rupture; Material Rupture
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687687 ↗MalfunctionMar 5, 2025Material Rupture; Material Rupture
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A BRACHIAL FISTULA. THE BALLOON BURST CIRCUMFERENTIAL AND CAME APART AS IT WAS INFLATED TO BURST PRESSURE IN THE FISTULA. IT WAS ABLE TO BE REMOVED FULLY AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527398 ↗MalfunctionFeb 13, 2025Difficult to Remove; Difficult to Remove
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. THE DEVICE HAS PERFORMED AS INTENDED. DURING WITHDRAWAL, THE BALLOON WAS VERY DIFFICULT TO REMOVE THROUGH THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378425 ↗MalfunctionFeb 13, 2025Difficult to Remove; Difficult to Remove
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. THE DEVICE HAS PERFORMED AS INTENDED. DURING WITHDRAWAL, THE BALLOON WAS REALLY DIFFICULT TO REMOVE THROUGH THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378407 ↗MalfunctionFeb 7, 2025Inflation Problem; Device Handling Problem; Inflation Problem; Device Handling Problem
THE PASSEO-35 XEO BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT. THE BALLOON COULD NOT BE INFLATED IN THE VENOUS STENOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21336296 ↗InjuryJan 15, 2025Fracture; Material Rupture; Fracture; Material Rupture
THE PASSEO-35 XEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE POSTERIOR TIBIAL ARTERY (PTA). DURING ATTEMPT OF PRE-DILATATION, THE PASSEO-35 XEO RUPTURED AT 15ATM. IT WAS ATTEMPTED TO REMOVE THE DEVICE BUT THE DEVICE FRACTURED AND A PART OF THE BALLOON REMAINED IN PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATION ROOM TO REMOVE THE FRACTURED PART. FINALLY, PATIENT WAS DISCHARGED HOME WITH NO FURTHER COMPLICATION.
Patient problems: Foreign Body In Patient
MAUDE report 21159682 ↗MalfunctionSep 19, 2024Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam
THE PASSEO-35 XEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT. AFTER DEFLATION, IT WAS NOT POSSIBLE TO REMOVE THE BALLOON CATHETER FROM THE 0.035 TERUMO GUIDEWIRE. THUS, BOTH DEVICES HAD TO BE WITHDRAWN AND WERE REPLACED BY USING A DIFFERENT BALLOON AND GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258272 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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