Z-1626-2009

Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule...

Name: Z-1626-2009 Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule...
Creator: Boston Scientific Corp
Published: 2009-05-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-05-05 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick... on 2009-05-05. 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, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1626-2009
Status: Terminated
Initiated: 2009-05-05
Posted: 2015-06-25
Terminated: 2010-10-13
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491. 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.
Quantity in commerce: 140
Distribution: Worldwide Distribution -- United States, India, Japan and Slovenia.
Product codes and lots: M00566490, Lot Numbers: 18893672, 11942231 and 12163810; and M00566491, Lot Numbers: 11934737 and 11996717.

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)