Single use hemostatic clips recalled for clip deployment and mechanical failures
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical 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 medical device recall involving a risk-of-harm product used during active clinical procedures where functional failures could potentially cause patient harm. No illnesses or injuries are reported in the source material.
Plain-English summary
Olympus Corporation of the Americas is recalling its Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX, a hemostatic metal clip intended for use in gastrointestinal tract procedures. The recall affects 13,707 units distributed nationwide, with lot numbers 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, and 2ZK (Catalog Number HX-202UR.A).
The recall was initiated due to complaints of clip deployment failures during clinical procedures. Reported issues include: the clip arm failing to open when the user pushes the slider; the clip arm failing to close when the user pulls the slider; and the clip detaching from target tissue earlier than expected after deployment. These malfunctions create hazardous situations where the clips fail to achieve their intended hemostatic function and may cause harm to patients.
Healthcare providers using these clips in gastrointestinal endoscopy procedures should be aware of these potential failures. If any of these deployment issues occur during a procedure, clinicians should take appropriate measures to address the situation and patient safety.
Healthcare providers should report any adverse events or malfunctions to Olympus Corporation and the FDA MedWatch program.
The recalled product
- Product
- Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Hemostatic clip
- Affected units
- 13,707
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 (9)
- UDI-DI: 04953170385933 Lot Numbers: 24K
- 25K
- 26K
- 27K
- 28K
- 29K
- 2XK
- 2YK
- 2ZK
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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