Z-0402-2016Class II

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

Name: Z-0402-2016 One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube
Creator: Boston Scientific Corp
Published: 2015-09-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-09-11 / Terminated

FDA source

Boston Scientific Corp began a recall of One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube on 2015-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0402-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Posted: 2015-12-10
Terminated: 2016-05-17
Recalling firm: Boston Scientific Corporation
Product: One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Product code: KGC Tube, Gastro-Enterostomy
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.
FDA root cause: Under Investigation by firm
Action: Boston Scientific Corp. sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated September 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you identify any product from the affected lot within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed recall instructions. You will receive replacements for all recalled product that is returned to Boston Scientific. If you are a distributor, or hospital please note that this recall is to the customer level. Please notify any customer who has received affected product. We are notifying affected worldwide regulatory authorities of this Recall Removal as required. Please read carefully through the enclosed Recall Removal Instructions. Your local Sales Representative can answer any questions that you may have regarding this Recall Removal. We regret any inconvenience that this action may cause, and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. We are committed to continuing to offer products that meet the highest quality standards that you expect from Boston Scientific. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to Boston Scientific by calling 1-866-868-4004.
Quantity in commerce: 22 units
Distribution: US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0402-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

Product code KGC

K910584Class IIOne Step Button(tm)Applied Medical Technologies / cleared 1991-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)