Biotronik Passeo-35 HPRecalls & reported problems across all models
Creagh Medical Limited · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of Biotronik Passeo-35 HP by Creagh Medical Limited in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2016 and Aug 5, 2025 — classified as 3 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (9 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 Biotronik Passeo-35 HP problems
Device problems
- Material Rupture9
- Material Puncture/Hole4
- Fracture3
- Deflation Problem2
- Detachment of Device or Device Component2
- Inflation Problem2
- Difficult to Advance1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient6
- Foreign Body In Patient3
- Insufficient Information2
- Rupture1
Biotronik Passeo-35 HP models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biotronik Passeo-35 HP 10/40/75Catheter, Angioplasty, Peripheral, Transluminal7 reports
- Biotronik Passeo-35 HP 8/40/75Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Biotronik Passeo-35 HP 8/80/75Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Biotronik Passeo-35 HP 12/40/75Catheter, Angioplasty, Peripheral, Transluminal2 reports
- Biotronik Passeo-35 HP 4/40/75Catheter, Angioplasty, Peripheral, Transluminal1 report
- Biotronik Passeo-35 HP 5/60/75Catheter, Angioplasty, Peripheral, Transluminal1 report
- Biotronik Passeo-35 HP 6/40/75Catheter, Angioplasty, Peripheral, Transluminal1 report
- Biotronik Passeo-35 HP 6/60/75Catheter, Angioplasty, Peripheral, Transluminal1 report
- Biotronik Passeo-35 HP 7/40/75Catheter, Angioplasty, Peripheral, Transluminal1 report
Recent Biotronik Passeo-35 HP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Fracture; Fracture
THE HIGH-PRESSURE BALLOON WAS USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE FOR TREATMENT OF A MODERATELY CALCIFIED LESION (STENOSIS DEGREE: 70%) IN A MODERATELY TORTUOUS BID-BRACHIAL ARTERY. THE TARGET VESSEL ALSO HAD A CALCIFICATION DEGREE OF APPROXIMATELY 70%. BALLOON INFLATION WAS ATTEMPTED AFTER PLACING INTO THE TARGET LESION. THE BALLOON BURST AT THE PRESSURE OF 21 ATM (RATED BURST PRESSURE WAS 23 ATM). THE BALLOON WAS PREPPED PER IFU. THERE WAS NO INDICATION OF ANY DAMAGE DURING DEVICE PREPARATION. NEGATIVE PRESSURE WAS CONFIRMED TO BE HELD DURING LOADING AND ADVANCING TO THE TARGET LESION AND THERE WAS NO LOSS OF NEGATIVE PRESSURE. THE DEVICE WAS NOT TORQUED OR TWISTED DURING LOADING. THE LESION LENGTH WAS NOTED TO BE APPROXIMATELY 30MM WITH A VESSEL DIAMETER OF 7MM. THERE WAS NO PATIENT INJURY. NO PARTS OF THE BALLOON REMAINED IN THE PATIENT. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY FIVE MINUTES. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22721174 ↗MalfunctionMay 16, 2024Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR INDICATED THE PROCEDURE WAS INITIALLY A FISTULOGRAM THAT REQUIRED ANGIOPLASTY. THE BALLOON WAS REPORTEDLY PREPPED PER IFU. THE VESSEL CALCIFICATION, DEGREE OF STENOSIS, AND LESION LENGTH WERE NOT AVAILABLE. THE ISSUE OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE INFLATION PRESSURE AT THE TIME OF RUPTURE WAS NOT RECORDED. THE PROCEDURE WAS STATED TO HAVE GONE WELL WITH THE USE OF ANOTHER BALLOON. THE PATIENT WAS REPORTEDLY FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333302 ↗MalfunctionMar 18, 2024Fracture; Fracture
THE BALLOON CATHETER WAS USED FOR A TREATMENT OF A LESION WITH 70% STENOSIS IN THE MILD LEFT BRACHIOCEPHALIC FISTULA (BCF). THE BALLOON WAS PREPARED AS PER IFU. THE BALLOON WAS INFLATED AT 18 ATM AND OPERATED AS EXPECTED DURING THE FIRST INFLATION. A SECOND INFLATION AT 18 ATM WAS PERFORMED AND THE BALLOON BURST BEFORE THE RATED BURST PRESSURE WAS REACHED. THERE WAS NO CALCIFICATION AND NOT TORTUOUS ANATOMY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926895 ↗InjuryJan 10, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture
THE 10MM HIGH PRESSURE BALLOON BURST WHILE INFLATING AT THE RATED BURST PRESSURE, 20ATM. THE BALLOON FRAGMENT WAS STUCK IN THE VEIN FIBROTIC TISSUE AND WAS UNABLE TO BE REMOVED. IT WAS ALSO NOTED THAT A PART OF THE BALLOON WAS ALSO STUCK AT THE TIP OF THE GUIDE SHEATH. SOME FORCE WAS APPLIED TO REMOVE THE BALLOON CATHETER AND GUIDE SHEATH FROM THE VEIN. PARTS OF THE BALLOON WERE ALSO BROKEN AND STUCK IN THE PATIENT ANATOMY NEAR THE PUNCTURE SITE. A VENOUS CUT DOWN WAS PREFORMED TO REMOVE THE REMAINING BALLOON. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT ANATOMY. THE REPORTED ISSUE RESULTED IN PROLONGED PATIENT HOSPITALIZATION. A PERMANENT CATHETER WAS ALSO INSERTED INTO THE PATIENT FOR DIALYSIS DUE TO THE TRAUMA SUSTAINED TO THE FISTULA BRACHIAL CEPHALIC VEIN. IT WAS NOTED THE LESION LOCATION WAS LOCATED DISTALLY. THE APPROXIMATE VESSEL DIAMETER WAS REPORTED TO BE 10MM WITH A STENOSIS DEGREE OF 70% AND LESION LENGTH OF 60MM. THE VESSEL HAD MILD TORTUOSITY AND SEVERE CALCIFICATION.
Patient problems: Foreign Body In Patient
MAUDE report 16133573 ↗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 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 ↗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 ↗MalfunctionSep 30, 2022Failure to Deflate; Failure to Deflate
ON 08SEP2022, MANUFACTURER BECAME AWARE OF THE EVENT, DESCRIBED AS "BALLOON DID NOT DEFLATE PROPERLY". PROCEDURE WAS PERFORMED ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510236 ↗MalfunctionMay 25, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
DURING INFLATION THE BALLOON BURST OCCURED LONGITUDINALLY AT 16ATM. THE BALLOON WAS SUCCESSFULLY RETRIEVED WITHOUT COMPLICATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11879574 ↗MalfunctionDec 15, 2020Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
THE PASSEO-35 HP DEVICE WAS UNABLE TO PASS THE SHEATH AND THE GUIDING WIRE. THE PASSEO-35 HP DEVICE WAS WITHDRAWN WITHOUT DIFFICULTIES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11010719 ↗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 ↗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 ↗MalfunctionJan 15, 2018Inflation Problem; Inflation Problem
THE PHYSICIAN TRIED TO INFLATE THE PASSEO-35HP BALLOON UP TO 20 ATM IN AVF WITH APPROXIMATELY 70% STENOSIS. DURING THE ATTEMPT, A POSSIBLE BALLOON TEAR WAS OBSERVED UNDER ANGIOGRAPHY; THE BALLOON HAD FAILED TO FULLY INFLATE AND THE SHAPE OF THE BALLOON LOOKED LIMP, EVEN SHOWING SLIGHT LEAK OF THE INFLATION MEDIUM. AFTER WITHDRAWING THE DEFECT DEVICE, A NEW PASSEO-35HP OF THE SAME SIZE WAS USED TO COMPLETE THE TREATMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7190040 ↗InjuryAug 2, 2017Material Rupture; Material Rupture
DURING THE TREATMENT OF A TIGHT LESION OF THE CENTRAL VEIN, THE BALLOON RUPTURED RADIALLY INTO TWO PARTS. WHILE WITHDRAWING THE TIP DISLODGED AND STUCK AT THE NECK OF THE STENOSIS AND COULD NOT BE REMOVED. AFTER 10 MINUTES THROMBUS DEVELOPED AT THE LESION. VASCULAR SURGEON ASSESSED THAT MIGRATION OF THE DEVICE WAS NOT POSSIBLE. PATIENT BEING MONITORED.
Patient problems: Foreign Body In Patient
MAUDE report 6760939 ↗
Other Creagh Medical Limited products
All Creagh Medical Limited 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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