CELLO™, Balloon Guide Catheter 1610580Recalls & reported problems
Fuji Systems Corporation · The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04544050120739), received between Jun 15, 2023 and Jan 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel2
- Break1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Burst Container or Vessel
MEDTRONIC RECEIVED REPORT THAT A CELLO BALLOON RUPTURED DURING A PROCEDURE TO TREAT A STROKE. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019387 ↗MalfunctionJul 24, 2024Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation
ADDITIONAL INFORMATION RECEIVED THAT DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. THERE WAS PREP PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816323 ↗MalfunctionJun 15, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS A CAS IN REAL. THE BALLOON WAS NOT LEFT IN THE PATIENT, IT SEPARATED FROM THE CATHETER BUT SOMEHOW IT WAS SUCCESSFULLY PULLED OUT WITH THE FULL SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17138302 ↗
Other Catheter, Percutaneous devices
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
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- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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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