Boston Scientific Corp: Medical Device Recall in 2015 - (Recall #: Z-0402-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 11, 2015

Date Posted: December 16, 2015

Recall Number: Z-0402-2016

Event ID: 72364

Reason for Recall:

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.

Status: Terminated

Product Quantity: 22 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated