Better-Bladder BB14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851997007004), received between Nov 25, 2019 and Oct 18, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

6 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.

Recalls naming this device

1. Apr 27, 2021Open, Classified

   The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

   Z-1862-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Nonstandard Device; Therapeutic or Diagnostic Output Failure

  ON (B)(6) 2021 THE COMPLAINANT CALLED AND INFORMED CTI THAT AN ADDITIONAL UNIT FROM LOT 5290-210401 FAILED THE REQUIRED LEAK TEST PRIOR TO USE. THIS UNIT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647246 ↗
• MalfunctionMay 26, 2021Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  ON 4/26/2021, CTI WAS NOTIFIED THAT THE PIGTAIL OF BB14 (LOT # 5290-201001) IN A WET CIRCUIT READIED FOR CLINICAL USE DISLODGED FROM THE HOUSING WHEN PULLED ON. NO PATIENT WAS INVOLVED. THE COMPLAINANT STATED THAT THE FACILITY DID NOT LEAK TEST PRIOR TO USE, AS REQUIRED IN THE IFU. ON 5/17/21 THE COMPLAINANT CALLED AND INFORMED CTI THAT AN ADDITIONAL UNIT FROM ANOTHER LOT, LOT 5290-210401, FAILED THE REQUIRED LEAK TEST PRIOR TO USE. THIS UNIT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891459 ↗
• MalfunctionMay 19, 2021Device Dislodged or Dislocated

  ON 4/19/2021, CTI WAS NOTIFIED BY THE ECMO COORDINATOR THAT DURING AN ECMO CASE THE PIGTAIL DISLODGED FROM THE HOUSING OF A BB14. THE FAILED BB14 WAS IMMEDIATELY REPLACED AND NO PATIENT INJURY WAS REPORTED. THE PRODUCT WAS IDENTIFIED AS LOT # 5290-201001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852675 ↗
• MalfunctionMay 17, 2021Leak/Splash; Nonstandard Device

  ON 4/16/2021, CTI WAS NOTIFIED BY THE ECMO COORDINATOR THAT WHILE CONDUCTING THE REQUIRED LEAK TESTS, A BB14 UNIT LEAKED. PLACING THE UNIT UNDER WATER WITH IT ¼" TUBES CLAMPED OFF AND PRESSURE APPLIED TO THE PIGTAIL SHOWED BUBBLES ESCAPING FROM THE JUNCTURE BETWEEN THE HOUSING AND PIGTAIL. WHEN WIPING THE PIGTAIL OFF, IT DISCONNECTED FROM THE HOUSING. THE PRODUCT WAS IDENTIFIED AS LOT # 5290-201001. THERE WAS NO PATIENT INVOLVED AS THE LEAK OCCURED PRIOR TO USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11835453 ↗
• MalfunctionNov 25, 2019Material Twisted/Bent

  THE END USER REPORTED THAT TWO BETTER-BLADDERS HAD BALLOONS WITH CRINKLING AND WERE NOT USABLE. THEY TRIED TO "REINFLATE" THEM UNSUCCESSFULLY. THE CRINKLES ARE MINOR AND HARD TO PICK UP IN A PHOTO (DO NOT SHOW WELL). THEY BECAME MORE EVIDENT WHEN WE PUT THEM ON 2 DIFFERENT PATIENTS AND HAD TO REMOVE THEM EMERGENTLY. THOSE WERE THROWN AWAY. FOUND IN OUR STOCK 4 BB14 AND 2 BBB38.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373246 ↗

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-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