Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.
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 risk-of-harm product (balloon leak in an obstetric device) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System, BD-OTS Obstetric Catheter (REF CTS-1000). The recall affects lots 0314-F-566, 0814-F-100, 0814-F-108, and 0814-V-068, which were manufactured since August 2014. The product is a prescription-only, sterile medical device distributed nationwide in the United States and in several international markets, including Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, the Netherlands, the Middle East, Scotland, Germany, and Wales.
The recall was initiated due to a potential for a balloon leak in the affected lots. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The agency classifies this recall as Class II.
Healthcare providers and patients should stop using the affected lots of the Ebb Complete Tamponade System. Clinical Innovations, LLC is the recalling firm responsible for managing the recall. Consumers and healthcare facilities should contact the manufacturer for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- Manufacturer
- Clinical Innovations, LLC
- Hazard
- 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 (4)
- Lots: 0314-F-566
- 0814-F-100
- 0814-F-108
- 0814-V-068
Distribution
Distributed nationwide across the United States.
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
Similar recalls
- HighClinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
FDA (Devices) · 2015-10-21
- SevereBoston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk
FDA (Devices) · 2021-01-20
- SevereBallard Closed Suction Catheters recalled for lack of sterility assurance
FDA (Devices) · 2025-04-23
- SevereBoston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk
FDA (Devices) · 2021-01-20
- SevereBallard Closed Suction Catheters recalled for sterility assurance failure
FDA (Devices) · 2025-04-23
- HighFDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
FDA (Devices) · 2024-10-02