Tube, Gastro-Enterostomy
FDA adverse event reports and recall history for tube, gastro-enterostomy (product code KGC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,227
- Deaths
- 18
- Injuries
- 219
- Malfunctions
- 985
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-12-10TerminatedUnder Investigation by firm
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
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 because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
- 2010-06-02TerminatedPackage design/selection
CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2010-06-02TerminatedPackage design/selection
ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2010-06-02TerminatedPackage design/selection
ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2010-06-02TerminatedPackage design/selection
ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2010-06-02TerminatedPackage design/selection
ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2010-06-02TerminatedPackage design/selection
ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
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 cause the sterility of the products to be compromised.
- 2009-09-17TerminatedEquipment maintenance
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
- 2009-09-17TerminatedEquipment maintenance
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF 000292, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
- 2009-09-17TerminatedEquipment maintenance
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
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