The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Covidien Endo GIA ™ Auto Suture™ Universal Articulating Loading Units with FDA registration number, DVR-5906, imported and distributed by Medtronic Philippines Inc.:
| Product Description | Item Code # | ItemGrp# | Lot/Batch # | Quantity |
| ROTICUL TR ENDO GIA 30-2.5 DLU | 030451 | MDT EMID Supplies | T9E081X | 12 pcs |
| Endo Gia Universal Articulating Loading Unit 30mm-2.5mm | 030451 | MDT EMID Supplies | T9G037X | 12 pcs |
| Endo Gia Universal Articulating Loading Unit 30mm-2.5mm | 030451 | MDT EMID Supplies | T9G029X | 6 pcs |
| Endo Gia Universal Articulating Loading Unit 30mm-2.5mm | 030451 | MDT EMID Supplies | T9G029X | 12 pcs |
| ENDO GIA R/OR 30 3.5MM | 030452
|
MDT EMID Supplies | T8l087X | 6 pcs |
| Endo GIA Roticulator 45mm 2.0mm | 030453 | MDT EMID Supplies | T7L033X | 12 pcs |
| Endo GIA Roticulator 45mm 2.0mm | 030453 | MDT EMID Supplies | T7L033X | 12 pcs |
| Endo GIA Roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T9F048X | 12 pcs |
| Endo GIA Roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T8K048X | 8 pcs |
| Endo GIA Roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T9F048X | 12 pcs |
| Endo GIA Roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T9F048X | 6 pcs |
| Endo GIA roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T9H146X | 6 pcs |
| Endo GIA Roticulator 45mm 3.5mm | 030455 | MDT EMID Supplies | T9M049X | 6 pcs |
| ENDO GIA R/OR 60 2.5MM X6 | 030457 | MDT EMID Supplies | T9D055X | 12 pcs |
| ENDO GIA R/OR 60 2.5MM X6 | 030457 | MDT EMID Supplies | T9E025X | 12 pcs |
| Endo GIA Roticulator 60mm 3.5mm | 030458 | MDT EMID Supplies | T9G159X | 6 pcs |
| Endo GIA Roticulator 60mm 3.5mm | 030458 | MDT EMID Supplies | T9G159X | 6 pcs |
| Endo GIA Roticulator 60mm 3.5mm | 030458 | MDT EMID Supplies | T9J030X | 12 pcs |
| Endo GIA Roticulator 60mm 3.5mm | 030458 | MDT EMID Supplies | T9L075X | 12 pcs |
Medtronic Philippines Inc. initiated the voluntary recall of the above-mentioned specific lots/batches of Covidien Endo GIATM Auto SutureTM universal articulating loading units in response to one confirmed customer report that the device staples were not properly formed upon application preventing adequate hemostasis. Investigation has shown this is due to manufacturing assembly error that can contribute to staple malformation.
The most common potential also exists for bleeding, anastomotic leak, pneumothorax or other delayed secondary complication including infection, peritonitis, sepsis, and increased risk of mortality. Manufacturing process improvements have been implemented to remediate this issue.
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Covidien Endo GIATM Auto SutureTM universal articulating loading units.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.