PlainRecalls
FDA Devices Moderate Class II Ongoing

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

Reported: June 28, 2023 Initiated: May 4, 2023 #Z-1987-2023

Product Description

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

Reason for Recall

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

Details

Units Affected
340 pieces
Distribution
US Nationwide distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled? ▼
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A. Recalled by Olympus Corporation of the Americas. Units affected: 340 pieces.
Why was this product recalled? ▼
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2023. Severity: Moderate. Recall number: Z-1987-2023.

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