Skip to content
Recall Observatory FDA recall evidence

Device product

US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

Z-1011-2019

February 04, 2019

Class II

Product summary

Firm
US Endoscopy Group Inc
Event
Event 82142
Status
Terminated
Classification
Class II
Quantity
483 units ( 325 units US and 158 OUS)
Official record key
device-enforcement:Z-1011-2019

Official wording

Reason: Potential esophageal laceration during a patient procedure

Code information: Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential esophageal laceration during a patient procedure