FDA Recalls Biliary Balloon Dilators for Design Nonconformance
Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.
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: This is a Class II FDA device recall with no reported illnesses or injuries associated with the design nonconformance. While balloon detachment presents potential for harm—including endoscopic retrieval needs and internal bleeding—the hazard remains theoretical without confirmed adverse events, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator, Reference Number QBD-8X3. The device is used to dilate strictures (narrowing) of the biliary tree during endoscopic procedures. Distribution was limited to the United States.
The recalled devices are nonconforming, meaning they do not comply with their design requirements. The devices may experience balloon detachment during use. Potential complications from balloon detachment include the need for endoscopic retrieval of the detached balloon, bleeding caused by the retrieval procedure, or less commonly, the balloon passing naturally without further intervention.
Hospitals and medical centers that have received devices from the affected lot numbers should immediately cease using them and quarantine remaining stock. Specific lot numbers are listed on the FDA recall notice. Healthcare providers should contact Wilson-Cook Medical Inc. for device return or replacement instructions. The FDA has assigned recall number Z-0462-2024 to this action.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- balloon-detachment
- internal-bleeding
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 (20)
- UDI/DI 00827002226562 (each)
- 10827002226569 (case)
- Lot Numbers: W4737768
- W4746516
- W4746916
- W4747433
- W4747834
- W4748247
- W4748468
- W4748476
- W4748944
- W4749747
- W4750013
- W4751335
- W4754263
- W4756372
- W4757274
- W4720844
- W4721266
- W4721791
Distribution
Distribution scope not specified by the agency.
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