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PUMA-G System™
Coaptech, Inc. · Model 0010204 · UDI-DI 00850026037029
KGC
Prescription
10
510(k) clearances
1,241
Adverse events (18 deaths)
25
Recalls
24
Facilities
Description
Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape and Safety PUSH PEG Kit)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-11 | Boston Scientific Corp | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices b |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
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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.