Z-0913-2009

Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific...

Name: Z-0913-2009 Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific...
Creator: Boston Scientific Corp
Published: 2008-12-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-12-30 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch... on 2008-12-30. The reason FDA records is "The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0913-2009
Status: Terminated
Initiated: 2008-12-30
Posted: 2009-01-28
Terminated: 2009-10-30
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
FDA root cause: Other
Action: Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.
Quantity in commerce: 2460 of all products
Distribution: Nationwide.
Product codes and lots: Inner pouch (UPN M00566530) packaged in outer cartons (UPN M00566531) with lot number 12080466 on both pouches.

Product code KNT

K031538Class IIEndovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp / cleared 2003-06-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)