Better-Bladder BB14

• FDA 510(k) K981284 decided 12 Aug 1998 Active
• FDA GUDID UDI-DI 00851997007004 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 00851997007004
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

Better-Bladder

Generic name

Cardiotomy reservoir

Model / Ref / Catalog

BB14

Primary DI / UDI-DI

00851997007004

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 — 0.25 Inch

Category: Cardiotomy reservoir

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

• CARDIOTOMY RESERVOIR by Shiley, Inc.
• VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT by Sorin Biomedical, Inc.
• CARDIOTOMY RESERVOIR W/FILTER BCR-3500 by American Bentley
• SCIMED R30 SILICONE ASSIST RESERVOIR by Scimed Life Systems, Inc.
• XTRA SEQUESTRATION SET X by SORIN GROUP ITALIA SRL
• HEMOBAG, MODEL HBBSD2000 by GLOBAL BLOOD RESOURCES LLC
• MODEL 4815 ADAPTER by Pace Medical
• MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER by Johnson & Johnson Professionals, Inc.
• CAPIOX SX HARDSHELL RESERVOIR by TERUMO MEDICAL CORPORATION
• PLEUR-EVAC CARDIOTOMY RESERVOIR by Deknatel, Inc.

• Bigger Better-Bladder BBB38 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. →