FDA Medical Device Recalls (openFDA)
Circulatory Technology Inc: 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 pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Recall number
- Z-2832-2016
- Recalling firm
- Circulatory Technology Inc
- Product
- 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 pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Status
- Terminated
- Initiated
- 2016-07-01
- Posted
- not on file
- Terminated
- 2018-06-14
- Reason
- The seal between the balloon and the housing may leak.
- Root cause
- Device Design
- Action
- The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.
- Quantity
- 20 units
- Distribution
- US Distribution to states of: LA, MI, NY, OH, OR & TX.
- Lot, serial or model codes
- Lot # 014648 USE BY: 09/01/2018
- 510(k) numbers
- ["K981284"]
- PMA numbers
- not on file
- Product code
- DTN
- Firm FEI
- 1000522036
- Firm city
- Oyster Bay
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28