Skip to content
Recall Observatory FDA recall evidence

Device product

One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

Z-0402-2016

September 11, 2015

Class II

Product summary

Firm
Boston Scientific Corp
Event
Event 72364
Status
Terminated
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-0402-2016

Official wording

Reason: Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

Code information: Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.

Distribution pattern: US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.