Agency classClass IIOur severity:High FDA (Devices)·Z-0459-2024·Announced 2023-12-13

FDA Recalls Quantum TTC Biliary Balloon Dilators Due to Design Nonconformance

Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.

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: FDA Class II recall for a medical device with potential for serious complications (balloon detachment requiring endoscopic retrieval and risk of internal bleeding). No illnesses, injuries, or deaths have been reported, placing this in the High category for risk-of-harm products without reported actual injury.

Plain-English summary

Wilson-Cook Medical Inc. is recalling 553 Quantum TTC Biliary Balloon Dilator devices (Model QBD-4X3) distributed in the United States. These devices are identified by specific lot numbers provided by the FDA.

The recalled devices do not comply with their design specifications. This nonconformance creates a risk of balloon detachment during endoscopic procedures. If detachment occurs, the device may require endoscopic retrieval, which can cause internal bleeding and other complications. In some cases, the detached balloon may pass through the body naturally without causing injury.

Healthcare providers and hospitals using these devices should discontinue use immediately and verify whether they have affected lot numbers. Contact Wilson-Cook Medical or the FDA for instructions on device return or safe disposal. Patients who have had procedures with these devices should contact their healthcare provider if they experience symptoms or complications.

The recalled product

Product: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Manufacturer: Wilson-Cook Medical Inc.
Category: Medical Device — Endoscopic Equipment
Hazard: balloon-detachment
internal-bleeding
device-defect
Affected units: 553

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 00827002226548 (each)
10827002226545 (case)
Lot Numbers: W4720848
W4721792
W4721795
W4722159
W4722981
W4723304
W4723846
W4724692
W4737576
W4738717
W4742525
W4743193
W4743605
W4743606
W4743607
W4743608
W4744022
W4744441

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Wilson-Cook Medical Inc.

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Same hazard · balloon detachment