BIBRecalls & reported problems across all models
B Braun Interventional Systems, Inc · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 6 models of BIB by B Braun Interventional Systems, Inc in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Oct 11, 2022 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
BIB recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 21, 2025Terminated
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Z-1754-2025 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported BIB problems
Device problems
- Material Rupture2
- Break1
- Device Markings/Labelling Problem1
- Improper or Incorrect Procedure or Method1
- Inadequacy of Device Shape and/or Size1
- Inadequate User Interface1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
BIB models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIB® 614396Catheter, angioplasty, peripheral, transluminal, dual-balloon1 recall0 reports
- BIB® 614440Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614444Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614445Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614446Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
- BIB® 614451Catheter, angioplasty, peripheral, transluminal, dual-balloon1 report
Recent BIB adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2022Break; Break
AS PER THE REPORT FROM THE USER FACILITY / FOREIGN DISTRIBUTOR - WE HAVE BEEN REPORTER FROM THE HOSPITAL OF BERN A PROBLEM WITH THE REFERENCE (B)(4). APPARENTLY THE OUTER BALLOON EXPLODED AT 2 BAR, THIS CAUSED PROBLEMS IN THE REMOVAL OF THE BALLOON. FORTUNATELY THE PROCEDURE COULD BE TERMINATED WITHOUT CONSEQUENCES. WE ARE TRYING TO GET MORE INFORMATION ON THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579712 ↗MalfunctionAug 26, 2022Off-Label Use; Material Rupture; Off-Label Use; Material Rupture
InjuryFeb 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
BIB USED IN MELODY VALVE CASE. COVERED MOUNTED CP STENT (CMCP033) DEPLOYED. 2 PAL MAZ DEPLOYED WITHIN THE CP. USED BIB# 614445 TO FLARE THE EDGE OF THE STENT. BIB RUPTURED CIRCUMFERENTIALLY INSIDE PATIENT. REQUIRED CARDIAC SURGICAL CUT DOWN TO GET EVERYTHING OUT SAFELY AND THEN FINISHED VALVE IMPLANT. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON. THE CATHETER SHAFT WAS NOT KINKED. A PRESTO INFLATION DEVICE WAS USED. THE INTRODUCER SHEATH WAS A 22 FR DRY SEAL. PATIENT HAS A TRUNCUS TYPE 2 CARDIAC ANATOMY. POST PROCEDURE PATIENT CONDITION: PATIENT FULLY RECOVERED WITH INCISION THAT WAS NOT NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 1/26/2021 - THE BIB THAT RUPTURED WAS USED TO DEPLOY THE SECOND OF THE PAL MAZ STENTS AND IT WAS USED TO FLARE THE PROXIMAL END OF THE STENT IMMEDIATELY AFTER DEPLOYMENT. ALSO THE BALLOON MARKERS ON THE BIB THAT RUPTURED WERE OFF - ACCOUNT MOUNTED THE STENT AT THE LOCATIONS OF THE BALLOON MARKERS HOOVER UPON INFLATION OF THE BALLOON IT WAS CLEAR THAT THE STENT WAS NOT CENTERED ON THE BALLOON. ACCOUNT IMPLANTED THE COVERED CP STENT INITIALLY FOLLOWED BY 2 SEPARATE PAL MAZ STENTS TO FURTHER REINFORCE THE RADIAL STRENGTH OF THE STENTED OUTFLOW T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11327328 ↗MalfunctionApr 23, 2019Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequate User Interface
ON (B)(6) 2019 NUMED RECEIVED A MEDWATCH REPORT FROM THE FDA THAT WAS SENT VIA USPS (MW5085855). THIS MEDWATCH REPORT WAS FROM THE USER FACILITY BUT LACKED USER FACILITY INFORMATION, CONTACT INFORMATION, AND AN ACCURATE LOT NUMBER FOR THE DEVICE. BASED ON THE STERILIZATION LOT NUMBER REFERENCED ON THE REPORT, NUMED WAS ABLE TO DETERMINE THE ACCURATE LOT NUMBER. NUMED CONTACTED THE DISTRIBUTOR IN THE U.S. FOR MORE INFORMATION ON THE DISTRIBUTION OF THE DEVICE AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "ON (B)(6) 2019 FROM THE ACCOUNT VIA EMAIL: "I AM CONTACTING YOU BECAUSE OF AN ISSUE THAT WE HAD WITH A BIB BALLOON DURING A PROCEDURE THIS WEEK AND JUST WANTED TO TALK TO YOU AND DISCUSS IT TO SEE IF THERE IS SOMETHING WE CAN DO TO RESOLVE A POTENTIAL PROBLEM IN THE FUTURE." BIS MEDICAL DEVICE SPECIALIST (MDS) SPOKE TO THE ACCOUNT AND SENT THIS MESSAGE: "MORE OF AN INVENTORY QUESTION AND NOT A PIR." ON (B)(6) 2019 - PER A CONVERSATION WITH BIS MDS AND PETER FLOSDORF: THE TECH PULLED AN INCORRECT SIZE BECAUSE OF LACK OF TRAINING AT THE ACCOUNT. THE TECH USED THE INNER BALLOON SIZE INSTEAD OF THE OUTER BALLOON SIZE. THE ACCOUNT WILL CONDUCT INTERNAL TRAINING TO RECTIFY. THIS IS
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8541022 ↗MalfunctionJul 24, 2018Material Rupture
THE PRODUCT PERFORMED WELL AND DID ITS JOB, BUT AFTER INFLATING FOR THE LAST TIME IT RUPTURED. THE BALLOON RUPTURED LONGITUDINALLY AT 3 ATM. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR: MAIN PULMONARY ARTERY VALVULOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE USED. A 12 F COOK INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS OK POST PROCEDURE. A SECOND BALLOON WAS NOT NEEDED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7713510 ↗
Other B Braun Interventional Systems, Inc products
All B Braun Interventional Systems, Inc 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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