The Recall Desk
HighFDA (Devices)·Z-0457-2024·Announced 2023-12-13

Biliary balloon dilators recalled due to design nonconformity and detachment risk

Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.

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: FDA Class II medical device recall with potential for serious harm including bleeding and need for endoscopic intervention; however, no illnesses or injuries have been reported, keeping the score at High rather than Severe.

Plain-English summary

Wilson-Cook Medical Inc. has recalled 731 QUANTUM TTC Biliary Balloon Dilator devices (Model QBD-10X3, Order Number G22657) distributed in the United States. The balloons are used to dilate strictures (narrowing) of the biliary tree during endoscopic procedures.

The recalled devices do not comply with their design requirements despite being manufactured correctly. The primary concern is that the balloon may detach from the catheter during use. If this occurs, the detached balloon could remain in the patient's bile duct.

If a balloon detaches, medical intervention may be necessary. Physicians may need to perform endoscopic retrieval to remove the object. This retrieval procedure carries the risk of bleeding complications. In some cases, the object may pass naturally without injury.

Consumers and healthcare providers should stop using these devices immediately. Contact Wilson-Cook Medical Inc. for instructions on device replacement and handling. Specific lot numbers are listed in the FDA recall notice.

The recalled product

Product
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Manufacturer
Wilson-Cook Medical Inc.
Category
Medical Device — Biliary Dilator
Hazard
Affected units
731

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 00827002226579 (each)
  • 10827002226576 (case)
  • Lot Numbers: W4746514
  • W4746515
  • W4753822
  • W4756371
  • W4756904
  • W4720845
  • W4721268
  • W4722642
  • W4722645
  • W4722982
  • W4723311
  • W4724690
  • W4738719
  • W4739842
  • W4740111
  • W4746917
  • W4747437
  • W4747835

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 →

Related recalls

Same manufacturer · Wilson-Cook Medical Inc.

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Same hazard · balloon detachment

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