Z-2193-2008

AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden...

Name: Z-2193-2008 AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden...
Creator: AGA Medical Corporation
Published: 2008-04-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-04-25 / Terminated / root cause: packaging

FDA source

AGA Medical Corporation began a recall of 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... on 2008-04-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2193-2008
Status: Terminated
Initiated: 2008-04-25
Posted: 2008-09-03
Terminated: 2010-10-13
Recalling firm: Abbott Medical
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 cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Product code: MJN Catheter, Intravascular Occluding, Temporary
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
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 131 (34 US, 97 OUS)
Distribution: 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
Product codes and lots: lot number M08B11-34

Product code MJN

K053440Class IIAmplatzer Sizing Balloon IIAga Medical Corp. / cleared 2005-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)