FDA Recall Terminated

AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. 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.

Recall: Z-1595-2011 · Initiated December 17, 2010

Recall

Recall Number: Z-1595-2011
Event Number: 57819
Firm: AGA Medical Corporation
FEI Number: 3005334138
Product Code: MJN
Status: Terminated
Root Cause: Employee error
Initiated: December 17, 2010
Posted: March 8, 2011
Terminated: March 29, 2012
Address: 5050 Nathan Ln N, Plymouth, MN, 55442-3209

Description

Reason

AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.

Action

AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA. For questions regarding this recall call 1-763-531-3175.

Distribution

Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom

Quantity