Bigger Better-Bladder BBB38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851997007011), received between Nov 21, 2019 and Mar 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Collapse” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K981284); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2020Collapse

  ON 2/24/2020, HOSPITAL NOTIFIED MANUFACTURER THAT TWO BIGGER BETTER-BLADDERS, MODEL BBB38, BEGAN TO COLLAPSE WITHIN 24 HOURS OF CLINICAL USE. THE FIRST BBB38 STARTED TO COLLAPSE UPON ECLS INITIATION ON (B)(6) 2020. THE 2ND COLLAPSED 12 HRS AFTER A CIRCUIT CHANGE ON (B)(6) 2020. THEY KEPT COLLAPSING AND WERE CHANGED WITH A BBB38 FROM ANOTHER LOT. THE PRODUCTS WERE USED ON THE SAME PATIENT. THE UNITS WERE REPLACED AND THERE WAS NO HARM OR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879086 ↗
• MalfunctionNov 21, 2019Defective Component; Gas/Air Leak; Pressure Problem

  FROM MEDWATCH REPORT (B)(4): THE BIGGER BETTER BLADDER IN THE ECMO CIRCUIT HAS AN AIR CHAMBER ON THE OUTSIDE FOR EQUILIBRATING THE PRESSURE DURING THE RUN THAT ENSURES APPROPRIATE NEGATIVE PRESSURE ON THE SYSTEM. DURING THE PREVIOUS NIGHT, SPECIALIST HAS TROUBLE MAINTAINING IN THE AIR CHAMBER TO THE RIGHT PRESSURE. THEY FOUND THE AIR CHAMBER PIGTAIL WAS LEAKING REQUIRING THE BLABBER TO BE CHANGED ON THE CIRCUIT. THE PATIENT WAS OFF BYPASS FOR 1:20 (ONE MINUTE 20 SECONDS) DURING THE CHANGE, BUT TOLERATED THE BRIEF TIME WITHOUT INCIDENT. POSSIBLY A MANUFACTURER DEFECT. EVENT WAS RELATED TO A DEFECTIVE CONSUMABLE WHICH WAS REPLACED WITH NO EVENT. MACHINE DID NOT MALFUNCTION-NO FURTHER ACTION BY BIOMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354816 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981284. One submission often covers many models, so check the product and lot details in each record.

• Z-1862-2021 · Apr 27, 2021 · Open, Classified
  The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
• Z-0817-2018 · Sep 22, 2017 · Terminated
  Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
• Z-1171-2018 · Sep 22, 2017 · Terminated
  **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manu
• Z-0057-2017 · Jul 1, 2016 · Terminated
  The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patie
• Z-2832-2016 · Jul 1, 2016 · Terminated
  The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressur
• Z-2050-2016 · Mar 3, 2016 · Terminated
  Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
• Z-1323-2010 · Jun 3, 2009 · Terminated
  The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster B