FDA Medical Device Recalls (openFDA)
Clinical Innovations, LLC: The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
- Recall number
- Z-0123-2016
- Recalling firm
- Clinical Innovations, LLC
- Product
- The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
- Status
- Terminated
- Initiated
- 2015-01-05
- Posted
- 2015-10-15
- Terminated
- 2016-04-21
- Reason
- Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
- Root cause
- Other
- Action
- Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
- Quantity
- 827 units
- Distribution
- Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
- Lot, serial or model codes
- Manufacturing lot 1214-F-403 and 1214-V-424
- 510(k) numbers
- ["K150573"]
- PMA numbers
- not on file
- Product code
- OQY
- Firm FEI
- 1000220650
- Firm city
- Murray
- Firm state
- UT
- 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