AGA Medical Corporation 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 cardiovascu Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 cardiovascu
Brand
AGA Medical Corporation
Lot Codes / Batch Numbers
lot number M08B11-34
Products Sold
lot number M08B11-34
AGA Medical Corporation is recalling AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Ave due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CT, FL, ID, IA, MD, MA, MI, MO, NH, NY, NC, OH, PA, SD, TN, TX, WI
Page updated: Jan 10, 2026