FDA Medical Device Recalls (openFDA)
Circulatory Technology Inc: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
- Recall number
- Z-2050-2016
- Recalling firm
- Circulatory Technology Inc
- Product
- Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
- Status
- Terminated
- Initiated
- 2016-03-03
- Posted
- not on file
- Terminated
- 2017-04-20
- Reason
- The seal between the balloon and the housing may leak.
- Root cause
- Device Design
- Action
- Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.
- Quantity
- 72 units
- Distribution
- US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
- Lot, serial or model codes
- Lot # 014603 USE BY: 9/2018
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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