Is this your brand? Sign in to claim ownership.

Aga Medical Corp.

Last updated May 23, 2026

What Aga Medical Corp. makes

Aga Medical Corp. manufactures cardiac defect occluders, including devices for closing atrial and ventricular septal defects, along with metallic embolization plugs for non-neurovascular embolization procedures. Their portfolio also includes single-use guidewires for cardiac and peripheral vascular applications, as well as atrial septal defect sizing plates for pre-procedural assessment.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Class III, with submissions recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (126)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Amplatzer™	9-ASD-012	FDA UDI	Class III	Active
Amplatzer™	Post Infarct Muscular VSD Occluder	FDA UDI	Class III	Active
Amplatzer™	9-AVP2-018	FDA UDI	Class II	Active
Amplatzer™	9-ASD-004	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-AVP2-003	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer™	9-EITV12F45/80	FDA UDI	Class II	Active
Amplatzer™	Septal Occluder	FDA UDI	Class III	Active
Amplatzer Torqvue Exchange System	K080994	FDA 510(k)	Class II	Active
Amplatzer Vascular Plug Ii Models: Avp2-004, Avp2-006, Avp2-008, Avp2-010, Avp2-012, Avp2-014, Avp2-016	K071125	FDA 510(k)	Class II	Active
Amplatzer Vascular Plug	K031810	FDA 510(k)	Class II	Active
Amplatzer Torqvue Delivery System	K072313	FDA 510(k)	Class II	Active
Amplatzer Torqvue 45x45 Delivery Sheath Amplatzer Torqvue La1 Delivery Sheath Amplatzer Torqvue La2 Selivery Sheath	K120120	FDA 510(k)	Class II	Active
Amplatzer Torqvue Low Profile Delivery System	K080757	FDA 510(k)	Class II	Active
Amplatzer Sizing Balloon	K993248	FDA 510(k)	Class II	Active
Amplatzer Vascular Plug 4	K113658	FDA 510(k)	Class II	Active
Amplatzer Reliant Catheter Delivery System	K070238	FDA 510(k)	Class II	Active
Amplatzer Noodlewire Guidewire	K053187	FDA 510(k)	Class II	Active
Amplatzer Sizing Balloon Ii	K053440	FDA 510(k)	Class II	Active
Amplatzer Torqvue 45degreex45degree Delivery Sheath, Models 9-Tv45x45-09f-100, 9-Tv45x45-10f-100	K083214	FDA 510(k)	Class II	Active
Amplatzer Torqvue 3 Delivery Sheath, Model 9-Tv3-08f104, 9-Tv3-08f54	K091793	FDA 510(k)	Class II	Active
Amplatzer Torqvue Fx	K121611	FDA 510(k)	Class II	Active
Amplatzer Vascular Plug Ii, Models Avp2-003, Avp2-018, Avp2-020, Avp2-022	K071699	FDA 510(k)	Class II	Active
Amplatzer Torq Vue 2 Delivery Sheath Model 9-Tv2-05f120, Model 9-Tv2-06f120, Modeltv-2-07f120	K093476	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

Aga Medical Corp. has 32 recall records initiated between November 23, 2004, and December 17, 2010, all of which are recorded as terminated. The recalls involved issues such as outer pouch seal integrity failures in specific delivery systems and sizing balloons, mislabeling of AMPLATZER PFO Occluders and sizing balloons with incorrect device sizes, and tubing residue from manufacturing deviations. Additional recalls addressed potential sterile barrier breaches in delivery system packaging, improper sterilization validation for AMPLATZER Vascular Plugs, and PTFE plastic lining fragments from occluder screws.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.