Balloon Guide Catheter BOB-895-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842429108543), received between Oct 21, 2022 and Sep 19, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Flaked” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 30, 2026Class IIOpen, Classified

   Due to an increase rate of balloon pinhole defects.

   Z-2912-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Flaked; Device Difficult to Setup or Prepare; Device Handling Problem; Flaked; Device Difficult to Setup or Prepare; Device Handling Problem

  IT WAS REPORTED THAT THIS MORNING WHILE PREPPING THE BOBBY FOR A CAROTID STENT CASE. THE TECH FOUND THAT THE BALLOON HAD LITTLE FLECKS OF MATERIAL STICKING OUT FROM THE BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097133 ↗
• MalfunctionSep 19, 2025Flaked; Device Difficult to Setup or Prepare; Device Handling Problem; Flaked; Device Difficult to Setup or Prepare; Device Handling Problem

  IT WAS REPORTED THAT THIS MORNING WHILE PREPPING THE BOBBY FOR A CAROTID STENT CASE. THE TECH FOUND THAT THE BALLOON HAD LITTLE FLECKS OF MATERIAL STICKING OUT FROM THE BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095983 ↗
• MalfunctionSep 18, 2025Flaked; Device Difficult to Setup or Prepare; Device Handling Problem; Flaked; Device Difficult to Setup or Prepare; Device Handling Problem

  IT WAS REPORTED THAT THIS MORNING WHILE PREPPING THE BOBBY FOR A CAROTID STENT CASE. THE TECH FOUND THAT THE BALLOON HAD LITTLE FLECKS OF MATERIAL STICKING OUT FROM THE BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092187 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT IS TO BE ADDED TO PREVIOUS SUBMISSION. INFORMATION RECEIVED NOTES THE FOLLOWING: EVENT SUMMARY : DURING THE ORIGINAL PROCEDURE ON (B)(6) 2024, THERE WAS THROMBUS SEEN DISTAL IN TWO MCA M2 BRANCHES FOLLOWING SUCCESSFUL THROMBECTOMY OF THE MCA M1 OCCLUSION. THIS MAY HAVE REPRESENTED PRE-EXISTING THROMBUS OF FRAGMENTATION OF THE ORIGINAL MCA M1 THROMBUS. THIS DISTAL MCA M2 BRANCH THROMBUS WAS TREATED WITH TWO ADDITIONAL PASSES WITH A STENT-RETRIEVER DURING THE ORIGINAL THROMBECTOMY. EVENT NAME : DISTAL EMBOLI EVENT : NEUROLOGICAL SEVERITY : MILD SAE? : NO UADE / USADE? : NO INTERVENTION - SPECIFY : CONTINUED THROMBECTOMY PASSES. OUTCOME - AE : RESOLVED WITHOUT SEQUELAE DATE OF RESOLUTION : ON (B)(6) 2024 RELATED TO: INITIAL THROMBECTOMY CLARIFICATION RECEIVED NOTES THE SITE UPDATED THE DISTAL EMBOLI IS POSSIBLY RELATED TO SOFIA AND BOBBY BALLOON GUIDE CATHETER, SOFIA DEVICE REMAINS AS CONCOMITANT DEVICE.

  Patient problems: Embolism/Embolus; Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 19198633 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED, SEE H10.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18145949 ↗
• MalfunctionAug 16, 2023Flaked; Flaked

  IT WAS REPORTED THAT THE BOBBY WAS INFLATED PRIOR TO USE AND WAS OBSERVED TO HAVE MATERIAL STICKING OUT FROM THE BALLOON. THE BALLOON WAS NOT USED IN THE PATIENT. NO PATIENT HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561270 ↗
• MalfunctionAug 15, 2023Flaked; Flaked

  IT WAS REPORTED THAT THE BOBBY WAS INFLATED PRIOR TO USE AND WAS OBSERVED TO HAVE MATERIAL STICKING OUT FROM THE BALLOON. THE BALLOON WAS NOT USED IN THE PATIENT. NO PATIENT HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553458 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT PRESENTED WITH A CERVICAL CAROTID OCCLUSION SECONDARY TO A SEVERE DISSECTION. REPORTEDLY, THE USE OF THE BOBBY BALLOON CATHETER WORSENED THE DISSECTION AND CAUSED VASOSPASM. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Vascular Dissection; Vasoconstriction

  MAUDE report 16838834 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT PRESENTED WITH OCCLUSION IN THE LEFT M2 SEGMENT OF THE MCA. REPORTEDLY, THE USE OF THE BOBBY BALLOON GUIDE CATHETER CAUSED A SEVERE DISSECTION AND VASOSPASM WITH FLOW LIMITATION IN THE CERVICAL ICA. PATIENT UNDERWENT A HEMICRANIECTOMY AND IS NOW IN INPATIENT REHAB.

  Patient problems: Reduced Blood Flow; Vascular Dissection; Vasoconstriction

  MAUDE report 16838031 ↗
• MalfunctionJan 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE PHYSICIAN NOTICED A FOREIGN MATERIAL WAS STICKING OUTSIDE OF THE BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16107926 ↗
• MalfunctionOct 21, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING PREPARATION, A BALLOON CATHETER'S HYDROPHILIC COATING WAS OBSERVED TO BE "COMING APART." THE BALLOON WAS SET ASIDE AND ANOTHER WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655571 ↗