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Amplatzer Piccolo™
ST. JUDE MEDICAL, INC. · Model 9-PDAP-03-06-L · UDI-DI 05415067030993
MAE
Prescription
0
510(k) clearances
1,091
Adverse events (62 deaths)
5
Recalls
11
Facilities
Description
Duct Occluder
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-09-06 | AGA Medical Corporation | 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. Th |
| 2005-09-06 | AGA Medical Corporation | 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. Th |
| 2005-09-06 | AGA Medical Corporation | 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. Th |
| 2005-09-06 | AGA Medical Corporation | 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. Th |
| 2005-09-06 | AGA Medical Corporation | 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. Th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.