Terminated

AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. The AMPLATZER Delivery System was designed to facilitate attachment, loading, delivery and deployment of the AMPLATZER Septal Occluder and comprised of a delivery sheath, dilator, loading device, plastic vise and delivery cable.

FDA Recall Z-2192-2008 · Posted 2008-09-03

Recall StatusTerminated

Date Initiated2008-04-25

Date Terminated2010-10-13

Product Quantity10 (9 US, 1 OUS)

Reason for Recall

AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devices to confirm the integrity of the ou

Firm Action

The firm Fed Ex'd and emailed a Field Inspection/Correction letter to customer 04/28/2008. The letter identified affected product, requested that customers check the outer package seal, and if it is incomplete the device should be returned for replacement. A form was also asked to be returned to AGA Medical. Contact AGA Medical at 1-763-513-9227 for assistance.

Root Cause

Packaging process control

Distribution Pattern

Within the US to include: AL, AZ, CA, CT, FL, IA, ID, MA, MD,MI, MO, NC, NH, NY, OH, PA, SD, TN, TX, WI. OUS to include: Brazil, Greece, Netherlands, Portugal, and Slovakia

Official Source

View FDA Recall →

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