CELLO™, Balloon Guide Catheter 1610590Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04544050120746), received between Feb 16, 2023 and Apr 28, 2026 — classified as 1 death, 1 injury, 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT A CELLO HAD A CATHETER LEAK. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A CAROTID ARTERY EMBOLIZATION PROCEDURE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A CAROTID ARTERY EMBOLIZATION PROCEDURE AND INTENDED TO USE CELLO (REF: (B)(4), LOT: 5300224). DURING PRE-USE TESTING, IT WAS FOUND THAT THE BALLOON COULD NOT BE INFLATED, AND LEAKAGE WAS OBSERVED AT THE DISTAL END. THE DEVICE WAS NOT USED FOR ANY BALLOON-RELATED OPERATION, AND NO REPLACEMENT DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS. THE CATHETER FLUSHED AND WAS INSPECTED PRIOR TO USE AND THE LEAK WAS OBSERVED DURING PREPARATION. ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016469 ↗
• MalfunctionJan 30, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275128 ↗
• MalfunctionJul 23, 2024Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT A CELLO BALLOON GUIDE CATHETER ENCOUNTERED AN ISSUE WHERE THE BALLOON TORE OFF. IT WAS THOUGHT TO HAVE BEEN DUE TO CALCIFICATION OF THE VEINS. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809141 ↗
• MalfunctionFeb 29, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR FLUSHED THE CATHETER AND ALL THE ACCESSORY DEVICES AS PER INSTRUCTIONS FOR USE (IFU) AND PLACED CELLO 9F AT THE COMMON CAROTID ARTERY (CCA) WITH THE HELP OF DILATOR AND 0.35 WIRE. AFTER SOME TIME, THE OPERATOR NOTICED THAT SALINE WAS LEAKING AT THE HUB OF THE CELLO. THERE WAS NO FORCE APPLIED WHILE CONNECTING THE Y CONNECTOR OR SYRINGE TO THE CATHETER HUB. THE CATHETER WAS INSPECTED OR TESTED PRIOR TO USE. THE LEAD WAS OBSERVED DURING USE. THE OPERATOR DECIDED TO WITHDRAW THE CELLO AND PUT A 7F LONG SHEATH, THEN THROUGH THE LONG SHEATH HE HAD COMPLETED MECHANICAL THROMBECTOMY (MT) WITH ALL OTHER DEVICES AND FINISHED THE CASE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ACUTE ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 5.1MM. ANCILLARY DEVICES INCLUDE A SHORT SHEATH, AND ACE 68 GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807216 ↗
• DeathFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED HEMORRHAGIC TRANSFORMATION OF A CEREBRAL INFARCTION FOLLOWING A PROCEDURE INVOLVING A REACT 68 CATHETER, CELLO 9F BALLOON CATHETER, AND SOLITAIRE STENT RETRIEVER. NO FURTHER TREATMENT OR HOSPITALIZATION WAS REQUIRED, AND THE EVENT RECOVERED/RESOLVED ON (B)(6) 2022. THE EVENT WAS NOT A NEW OR RECURRENT STROKE, AND WAS NOT THE RESULT OF A DEVICE DEFICIENCY. THE PATIENT'S MRS SCORE WAS 3, AND THEIR NIHSS SCORE WAS 20. THE SITE ASSESSED THE EVENT AS CAUSED BY THE DISEASE UNDER STUDY, AND NOT RELATED TO THE DEVICE, THE PROCEDURE, OR AN UNDERLYING CONDITION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR 3 CLOTS. THE FIRST WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY BELOW THE CAROTID T, THE SECOND IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA), AND THE THIRD LOCATED IN THE M2 SEGMENT OF THE LEFT MCA. THE PATIENT'S PRE-PROCEDURE MTICI SCORE WAS 0, AND POST-PROCEDURE IT WAS 2C. ADDITIONAL INFORMATION RECEIVED REPORTED THE HEMORRHAGIC TRANSFORMATION OF THE STROKE PATIENT INDEX STROKE ULTIMATELY HAD A FATAL OUTCOME. THE PATIENT HAD UNDERGONE A THROMBECTOMY P

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16454670 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CEC ADJUDICATED THIS EVENT AS CAUSAL TO THE STUDY PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Rupture; Stroke/CVA

  MAUDE report 16390726 ↗