Bigger Better-Bladder BBB38

• FDA 510(k) K981284 decided 12 Aug 1998 Active
• FDA GUDID UDI-DI 00851997007011 listed 3 Oct 2016 Listed

• 3 recalls, same reason

  • Ongoing Z-1862-2021 FDA Class II ·initiated 27 Apr 2021
  • Terminated Z-1171-2018 FDA Class II ·initiated 22 Sep 2017
  • Terminated Z-0817-2018 FDA Class II ·initiated 22 Sep 2017

  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.

• 2 recalls, same reason

  • Terminated Z-2832-2016 FDA Class II ·initiated 1 Jul 2016
  • Terminated Z-2050-2016 FDA Class II ·initiated 3 Mar 2016

  The seal between the balloon and the housing may leak.

• • Terminated Z-0057-2017 FDA Class III ·initiated 1 Jul 2016

  Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

• • Terminated Z-1323-2010 FDA Unclassified (pre-2012) ·initiated 3 Jun 2009

  During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.

1. 12 Aug 1998 Cleared FDA 510(k) K981284
2. 3 Jun 2009 Recall initiated FDA recalls Z-1323-2010
3. 3 Mar 2016 Recall initiated FDA recalls Z-2050-2016
4. 1 Jul 2016 Recall initiated FDA recalls Z-2832-2016
5. 1 Jul 2016 Recall initiated FDA recalls Z-0057-2017
6. 3 Oct 2016 Listed FDA GUDID 00851997007011
7. 22 Sep 2017 Recall initiated FDA recalls Z-1171-2018
8. 22 Sep 2017 Recall initiated FDA recalls Z-0817-2018
9. 27 Apr 2021 Recall initiated FDA recalls Z-1862-2021

Trade name

Bigger Better-Bladder

Generic name

Cardiotomy reservoir

Model / Ref / Catalog

BBB38

Primary DI / UDI-DI

00851997007011

510(k) Number

K981284 ↗

FDA product code

DTN

GMDN term

Cardiotomy reservoir

Device class

Class II

Regulation number

870.4400

GUDID distribution status

In Commercial Distribution

Sterilisation method

Ethylene Oxide

Size

Lumen/Inner Diameter — 0.375 Inch

Category: Cardiotomy reservoir

Other devices filed under FDA product code DTN (RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS).

• MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL by Medtronic Cardiac Surgery
• MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM by Avecor Cardiovascular, Inc.
• SOFT VENOUS RESERVOIR by Gish Biomedical, Inc.
• MODIFIED CARDIOTOMY RESERVOIR 5M1470 by 3M Health Care, Sarns
• SUCKER CARDIOTOMY RETURN, C.P. BYPASS by Electromedics, Inc.
• VENUOS RESERVOIR BAG BMR-1900 by American Bentley
• ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR by Electromedics, Inc.
• SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS by Sorin Biomedical, Inc.
• VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX by Gish Biomedical, Inc.
• SHILEY UTILITY RESERVOIR by Shiley, Inc.

• Better-Bladder BB14 Open recall

  Class II

  FDA 510(k) K981284 Active Cleared 12 Aug 1998 GUDID on market

• The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500

  Class II

  FDA 510(k) K012942 Active Cleared 5 Nov 2001

• Initary Better Bladder-Pediatric

  Class II

  FDA 510(k) K140321 Active Cleared 17 Apr 2014

• Better-Tubing

  Class II

  FDA 510(k) K964205 Active Cleared 8 Apr 1998

See all devices from Circulatory Technology, Inc. →