Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.
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 an FDA Class II medical device with reported functional failures during clinical use. No injuries, hospitalizations, or deaths have been reported. The rubric classifies risk-of-harm products without reported injury as High (score 3).
Plain-English summary
Olympus Corporation of the Americas is recalling 340 units of the QUICKCLIP PRO 165 CM hemostatic clip (catalog number HX-202LR.A). This is a single-use device designed to control bleeding in the gastrointestinal tract during endoscopic procedures. The affected lot numbers are 24K, 27K, 29K, 2XK, and 2YK, distributed nationwide in the United States.
The recall was initiated due to reports of clip deployment failures occurring during clinical procedures. Complaints indicate that the clip arm does not open when the user pushes the slider, does not close when the user pulls the slider, and may detach from target tissue earlier than expected after deployment. These failures prevent the clips from achieving their intended hemostatic function, creating hazardous situations where the device does not work as expected.
This recall affects patients who underwent gastrointestinal endoscopy procedures using clips from the affected lot numbers.
The recalled product
- Product
- Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- deployment-failure
- mechanical-failure
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 (5)
- UDI-DI: 04953170385919 Lot Numbers: 24K
- 27K
- 29K
- 2XK
- 2YK
Distribution
Distributed nationwide across the United States.
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