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AGA Medical Corporation AMPLATZER Delivery System, 10… recallZ-2192-2008 · AGA Medical Corporation · initiated Apr 25, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AGA Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-2192-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 25, 2008
Posted by the FDA
Sep 3, 2008
Recalling firm
AGA Medical Corporation
Quantity
10 (9 US, 1 OUS)
FDA submissions
P000039, P020024
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 description

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.

Code information (models, lots, serial numbers)

lot number M07K29-32

Other devices under the same FDA submission

9 devices cleared under P000039, P020024 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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