Quantum TTC Biliary Balloon Dilator Recall Due to Balloon Detachment Risk
Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.
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 device has a design defect creating risk-of-harm (balloon detachment) but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injuries score 3 (High).
Plain-English summary
Wilson-Cook Medical Inc. is recalling 157 units of the Quantum TTC Biliary Balloon Dilator (Model QBD-8X3-E, Order Number G22766) distributed in the United States. This medical device is used to dilate strictures (narrowing) of the biliary tree during endoscopic procedures.
The recalled devices were manufactured correctly but do not comply with their design requirements. The primary concern is that the balloon may detach from the catheter during use. When detachment occurs, potential consequences include endoscopic retrieval of the device, bleeding from the retrieval procedure, or the balloon may pass naturally without causing injury.
Healthcare providers who have these devices should stop using them immediately. The recall involves 38 specific lot numbers. Providers with questions should contact Wilson-Cook Medical Inc. or the FDA.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- balloon-detachment
- bleeding
- device-retrieval
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 00827002227668 (each)
- 10827002227665 (case)
- Lot Numbers: W4756462
- W4756900
- W4720847
- W4722980
- W4723309
- W4723843
- W4724323
- W4739834
- W4739836
- W4740110
- W4746517
- W4748042
- W4749743
- W4750261
- W4750868
- W4751105
- W4751508
- W4751913
Distribution
Distribution scope not specified by the agency.
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