FDA Medical Device Recalls (openFDA)
AGA Medical Corporation: 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.
- Recall number
- Z-2192-2008
- Recalling firm
- AGA Medical Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-04-25
- Posted
- 2008-09-03
- Terminated
- 2010-10-13
- Reason
- 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
- 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
- 10 (9 US, 1 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
- Lot, serial or model codes
- lot number M07K29-32
- 510(k) numbers
- not on file
- PMA numbers
- ["P000039","P020024"]
- Product code
- not on file
- Firm FEI
- 3005334138
- Firm city
- Golden Valley
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28