Terminated

Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6675, inner pouch UPN M00566750 and outer carton UPN M00566751. 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.

FDA Recall Z-1629-2009 · Posted None

Recalling FirmBoston Scientific Corp

Recall StatusTerminated

Product CodeKNT

Date Initiated2009-05-05

Date Terminated2010-10-13

Product Quantity525

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States, India, Japan and Slovenia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031538ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KITBoston Scientific Corp · 2003-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.