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Amplatzer Delivery Systems (45-degree curve). order no.… recallZ-0350-05 · AGA Medical Corporation · initiated Nov 23, 2004

Terminated All recalls posted in December 2004

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

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDA root cause category: Other

What the company is doing

Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.

Recall details

Recall number
Z-0350-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 23, 2004
Posted by the FDA
Dec 24, 2004
Recalling firm
AGA Medical Corporation
Quantity
1329
Product code
GBK
FDA submissions
P000039, P020024
Distribution
Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

Product description

Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchang Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

Code information (models, lots, serial numbers)

00E01-13, M02K07-44, M03C24-17, M03E27-07, M03F18-09, M03L11-45, M04B09-16, M04E27-19

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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