Better-Bladder (Bb)

• 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. 22 Sep 2017 Recall initiated FDA recalls Z-1171-2018
7. 22 Sep 2017 Recall initiated FDA recalls Z-0817-2018
8. 27 Apr 2021 Recall initiated FDA recalls Z-1862-2021

510(k) Number

K981284 ↗

FDA product code

DTN

Device class

Class II

Regulation

21 CFR Part 870.4400

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass).

• DISPOSABLE CARDIOTOMY; H-700F, H-700 by C. R. Bard, Inc.
• TRAUMAFUSE RAPID INFUSION DEVICE by The Traumafuse Co.
• MAXIMA FORTE HARDSHELL VENOUS RESERVOIR by MEDTRONIC VASCULAR, INC.
• WILLIAM HARVEY H-4720 NON-FILTERED CAR by C. R. Bard, Inc.
• SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR by Sorin Group Italia S.R.L.
• DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) by Dideco S.P.A.
• CARDIOPLEGIA RESERVOIR CAS-2000 by American Bentley
• BLOOD RESERVOIR by Delta Medical Industries
• INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C by Sorin Group Italia S.R.L.
• BIOCOR 200 HARDSHELL VENOUS RESERVIOR by Minntech Corp.

• Better-Bladder BB14 Open recall

  Class II

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

• 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

See all devices from Circulatory Technology, Inc. →