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Aga Medical Corp.

Last updated May 23, 2026

Information

Country: US
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Catalogue (126)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-AVP2-022	FDA UDI	Class II	Active
Amplatzer™	9-ASD-006	FDA UDI	Class III	Active
Amplatzer™	9-ASD-032	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ITV06F180/80	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-PLUG-010	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ASD-010	FDA UDI	Class III	Active
Amplatzer™	9-EITV09F45/80	FDA UDI	Class II	Active
Amplatzer™	9-AVP2-008	FDA UDI	Class II	Active
Amplatzer™	Vascular Plug 4	FDA UDI	Class II	Active
Amplatzer™	9-PLUG-006	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Guidewire	FDA UDI	Class II	Active
Amplatzer™	9-ITV09F45/80	FDA UDI	Class II	Active
Amplatzer™	9-ASD-007	FDA UDI	Class III	Active
Amplatzer™	9-PLUG-012	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ASD-014	FDA UDI	Class III	Active
Amplatzer™	9-TV45X45-12F-100	FDA UDI	Class II	Active
Amplatzer™	9-ASD-008	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ASD-038	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ITV09F180/80	FDA UDI	Class II	Active
Amplatzer™	9-ASD-020	FDA UDI	Class III	Active
Amplatzer™	9-PLUG-014	FDA UDI	Class II	Active
Amplatzer™	9-PLUG-008	FDA UDI	Class II	Active
Amplatzer™	9-AVP2-012	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Vascular Plug 4	FDA UDI	Class II	Active
Amplatzer™	9-ITV08F45/60	FDA UDI	Class II	Active
Amplatzer™	Vascular Plug 4	FDA UDI	Class II	Active
Amplatzer™	9-EITV08F180/80	FDA UDI	Class II	Active
Amplatzer™	9-ASD-015	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ITV08F180/80	FDA UDI	Class II	Active
Amplatzer™	9-AVP2-014	FDA UDI	Class II	Active
Amplatzer™	9-AVP2-016	FDA UDI	Class II	Active
Amplatzer™	9-TV45X45-14F-100	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-ASD-022	FDA UDI	Class III	Active
Amplatzer™	9-ASD-019	FDA UDI	Class III	Active
Amplatzer™	9-ITV12F45/80	FDA UDI	Class II	Active

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FDA Recalls (32)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 17, 2010	Z-1595-2011	—	terminated	AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package.
Dec 18, 2009	Z-1101-2010	—	terminated	In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.
Apr 25, 2008	Z-2193-2008	—	terminated	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
Apr 25, 2008	Z-2192-2008	—	terminated	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
Oct 2, 2006	Z-0255-2007	—	terminated	AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
Oct 2, 2006	Z-0257-2007	—	terminated	AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
Oct 2, 2006	Z-0256-2007	—	terminated	AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
Jun 1, 2006	Z-0052-2007	—	terminated	AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.
Jun 1, 2006	Z-0053-2007	—	terminated	AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The affected product was not distributed within the United States and does not affect U.S. consignees.
Sep 6, 2005	Z-0464-06	—	terminated	The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
Sep 6, 2005	Z-0461-06	—	terminated	The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
Sep 6, 2005	Z-0462-06	—	terminated	The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
Sep 6, 2005	Z-0463-06	—	terminated	The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
Sep 6, 2005	Z-0465-06	—	terminated	The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
Sep 1, 2005	Z-0127-06	—	terminated	Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
Nov 23, 2004	Z-0366-05	—	terminated	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.
Nov 23, 2004	Z-0360-05	—	terminated	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.
Nov 23, 2004	Z-0350-05	—	terminated	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.
Nov 23, 2004	Z-0365-05	—	terminated	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.
Nov 23, 2004	Z-0358-05	—	terminated	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.
Nov 23, 2004	Z-0362-05	—	terminated	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.
Nov 23, 2004	Z-0359-05	—	terminated	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.
Nov 23, 2004	Z-0357-05	—	terminated	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.
Nov 23, 2004	Z-0355-05	—	terminated	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.
Nov 23, 2004	Z-0364-05	—	terminated	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.
Nov 23, 2004	Z-0351-05	—	terminated	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.
Nov 23, 2004	Z-0356-05	—	terminated	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.
Nov 23, 2004	Z-0361-05	—	terminated	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.
Nov 23, 2004	Z-0352-05	—	terminated	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.
Nov 23, 2004	Z-0353-05	—	terminated	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.
Nov 23, 2004	Z-0363-05	—	terminated	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.
Nov 23, 2004	Z-0354-05	—	terminated	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.