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Terminated

AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. A triple lumen balloon catheter with 3 radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4 mm apart and one marker band 15 mm proximal of that pair. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

FDA Recall Z-2193-2008 · Posted 2008-09-03

Recalling FirmAGA Medical Corporation
Recall StatusTerminated
Product CodeMJN
Date Initiated2008-04-25
Date Terminated2010-10-13
Product Quantity131 (34 US, 97 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053440AMPLATZER SIZING BALLOON IIAga Medical Corp. · 2005-12-30

Official Source

View FDA Recall →

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

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