Occluder, Patent Ductus, Arteriosus
Unknown
Recent MDR events
1,071 adverse event reports on file
- Amplatzer Duct Occluder IIJul 30, 2026MalfunctionAbbott Medical2135147-2026-05197
- Amplatzer Duct Occluder IIJul 30, 2026InjuryAbbott Medical2135147-2026-05198
- Amplatzer Duct OccluderJul 30, 2026InjuryAbbott Medical2135147-2026-05201
- AMPLATZER PICCOLOJul 21, 2026MalfunctionAbbott Medical2135147-2026-04998
- AMPLATZER PICCOLOJul 21, 2026InjuryAbbott Medical2135147-2026-05000
- AMPLATZER PICCOLOJul 21, 2026DeathAbbott Medical2135147-2026-05001
- AMPLATZER DUCT OCCLUDER IIJul 13, 2026InjuryAbbott Medical2135147-2026-04809
- AMPLATZER DUCT OCCLUDER IIJul 13, 2026MalfunctionAbbott Medical2135147-2026-04827
- AMPLATZER DUCT OCCLUDERJul 10, 2026MalfunctionAbbott Medical2135147-2026-04779
- AMPLATZER DUCT OCCLUDERJul 1, 2026MalfunctionAbbott Medical2135147-2026-04600
Event type breakdown
Recalls
5 recall events for this product code
- AGA Medical CorporationTerminatedJan 31, 2006
AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mende
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.
Z-0461-06 · View FDA record ↗ - AGA Medical CorporationTerminatedJan 31, 2006
AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mende
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.
Z-0462-06 · View FDA record ↗ - AGA Medical CorporationTerminatedJan 31, 2006
AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mende
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.
Z-0463-06 · View FDA record ↗ - AGA Medical CorporationTerminatedJan 31, 2006
AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mend
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.
Z-0464-06 · View FDA record ↗ - AGA Medical CorporationTerminatedJan 31, 2006
AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Men
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.
Z-0465-06 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Abbott Medical
Plymouth, MN, US
Synergy Health Ast, Srl
Alajuela, CR
Midwest Sterilization Corp.
JACKSON, MO, US
Abbott Medical Costa Rica Limitada (structural Heart)
El Coyol Alajuela, CR
Sterigenics U.s., Llc
Salt Lake City, UT, US
Isomedix Operations, Inc.
Minneapolis, MN, US
St. Jude Medical
Roseville, MN, US
Abbott Medical
Saint Paul, MN, US
Pfm Medical Msg Gmbh
Nonnweiler Saarland, DE
Pfm Medical, Inc
Carlsbad, CA, US
Pfm Medical Mepro Gmbh
Nonnweiler-Otzenhausen Saarland, DE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.