Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
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: This is an FDA Class II medical device recall involving failures of a hemostatic clip used in invasive gastrointestinal procedures. Although no illnesses or injuries have been reported, the source describes deployment failures creating hazardous situations that prevent the device from achieving its intended function. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling QUICKCLIP PRO 165CM single-use hemostatic clips (Catalog Number HX-202LR.B) distributed nationwide in the United States. The affected lot numbers are 24K, 26K, 27K, 29K, 2XK, and 2YK. These clips are used to control bleeding during gastrointestinal procedures.
The recall was issued due to complaints of deployment failures occurring during clinical use. The clip may fail to function properly in three ways: the clip arm may not open when the user pushes the slider, the clip arm may not close when the user pulls the slider, or the clip may detach from the target tissue earlier than expected after being deployed. When these failures occur, the clip cannot achieve its intended hemostatic function, creating hazardous situations during procedures.
The recalled product
- Product
- Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 45
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 (6)
- UDI-DI: 04953170385926 Lot Numbers: 24K
- 26K
- 27K
- 29K
- 2XK
- 2YK
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas 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.
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