FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
- Recall number
- Z-0402-2016
- Recalling firm
- Boston Scientific Corp
- Product
- One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
- Status
- Terminated
- Initiated
- 2015-09-11
- Posted
- 2015-12-10
- Terminated
- 2016-05-17
- 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.
- 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
- 22 units
- Distribution
- US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K910584"]
- PMA numbers
- not on file
- Product code
- KGC
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28