Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device intended for postpartum hemorrhage control where a defect (balloon leak) could prevent therapy delivery, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. The recall addresses a potential balloon leak that may affect the device's ability to deliver therapy when needed. The product is intended for use in providing temporary control or reduction of postpartum uterine bleeding.
The recall involves 827 units from manufacturing lots 1214-F-403 and 1214-V-424. These units were distributed nationwide to Mississippi, Maryland, Tennessee, North Carolina, Indiana, Florida, Alabama, and Louisiana, as well as to France.
Healthcare providers and consumers should stop using the affected devices and contact Clinical Innovations, LLC for further instructions on how to return or dispose of the product.
The recalled product
- 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.
- Manufacturer
- Clinical Innovations, LLC
- Affected units
- 827
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufacturing lot 1214-F-403 and 1214-V-424
Distribution
Related recalls
Same manufacturer · Clinical Innovations, LLC
See all →- ModerateKiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage
FDA (Devices) · 2026-05-06
- HighClinical Innovations Sweetums Sucrose Solution Vials Recalled for Contamination
FDA (Food) · 2022-09-07
- HighSucrose solution vials recalled nationwide for contamination and leaking
FDA (Food) · 2022-09-07
- HighSweetums Sucrose Solution Recalled for Contamination and Leaking Cups
FDA (Food) · 2022-09-07
- HighClinical Innovations Recalls ROM Plus Collection Kits Due to Swab Defect
FDA (Devices) · 2020-12-16
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12