Hemostatic Clip Device Recalled Due to Deployment Failures
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
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 documented complaints of device malfunction during clinical use. While no hospitalization or injury reports are mentioned in the source, the risk-of-harm potential in a procedural medical device where failures occurred during patient procedures warrants a High severity rating.
Plain-English summary
Olympus Corporation of the Americas is recalling QUICKCLIP PRO 230CM hemostatic metal clips used for gastrointestinal procedures. The recall affects 3,795 units distributed nationwide across the United States.
The recall was initiated due to reported clip deployment failures during clinical procedures. The FDA received complaints documenting three types of malfunction: clips that fail to open when the user activates the deployment mechanism, clips that fail to close properly, and clips that detach from the target tissue earlier than expected after being placed in the procedure. These mechanical failures could prevent the device from functioning as intended and potentially cause patient harm.
Affected lot numbers are: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, and 2ZK. The product identifier is Catalog Number HX-202UR.B, with UDI-DI 04953170385940. Healthcare providers who have received this device should contact Olympus Corporation of the Americas for further instructions regarding use or replacement of affected units.
The recalled product
- Product
- Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- device-malfunction
- deployment-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 (9)
- UDI-DI: 04953170385940 Lot Numbers: 24K
- 25K
- 26K
- 27K
- 28K
- 29K
- 2XK
- 2YK
- 2ZK
Distribution
Distributed nationwide across the United States.
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