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Padlock Clip
US Endoscopy · Model C910001 · UDI-DI 00816765013793
PKL
Prescription
2
510(k) clearances
7,243
Adverse events (25 deaths)
6
Recalls
54
Facilities
Description
The Padlock Clip defect closure system is used in flexible endoscopy for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-03 | Wilson-Cook Medical Inc. | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2019-02-04 | US Endoscopy Group Inc | Potential esophageal laceration during a patient procedure |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
