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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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