The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Medtronic Valiant Naviation™ Thoracic Stent Graft System with FDA registration numbers, MDR-10572A, manufactured by Medtronic Inc., imported and distributed by Medtronic Philippines, Inc.:
| Product Name | Model #/ CFN | Product Name | Model #/ CFN |
| Stent Graft | VNMC2020C94TE | Stent Graft | VNMC4646C95TU |
| VNMC2020C94TJ | VNMF2020C96TE | ||
| VNMC2020C94TU | VNMF2020C96TU | ||
| VNMC2222C180TE | VNMF2222C185TE | ||
| VNMC2222C180TJ | VNMF2222C185TU | ||
| VNMC2222C180TU | VNMF2222C96TE | ||
| VNMC2222C94TE | VNMF2222C96TJ | ||
| VNMC2222C94TJ | VNMF2222C96TU | ||
| VNMC2222C94TU | VNMF2520C185TE | ||
| VNMC2520C186TE | VNMF2520C185TJ | ||
| VNMC2520C186TJ | VNMF2520C185TU | ||
| VNMC2520C186TU | VNMF2525C185TE | ||
| VNMC2525C180TE | VNMF2525C185TJ | ||
| VNMC2525C180TJ | VNMF2525C185TU | ||
| VNMC2525C180TU | VNMF2525C96TE | ||
| VNMC2525C94TE | VNMF2525C96TJ | ||
| VNMC2525C94TJ | VNMF2525C96TU | ||
| VNMC2525C94TU | VNMF2822C173TE | ||
| VNMC2822C207TE | VNMF2822C173TJ | ||
| VNMC2822C207TJ | VNMF2822C173TU | ||
| VNMC2822C207TU | VNMF2828C174TE | ||
| VNMC2828C182TE | VNMF2828C174TJ | ||
| VNMC2828C182TJ | VNMF2828C174TU | ||
| VNMC2828C182TU | VNMF2828C97TE | ||
| VNMC2828C90TE | VNMF2828C97TJ | ||
| VNMC2828C90TJ | VNMF2828C97TU | ||
| VNMC2828C90TU | VNMF3125C173TE | ||
| Stent Graft | VNMC3125C207TE | Stent Graft | VNMF3125C173TJ |
| VNMC3125C207TJ | VNMF3125C173TU | ||
| VNMC3125C207TU | VNMF3131C174TE | ||
| VNMC3131C182TE | VNMF3131C174TJ | ||
| VNMC3131C182TJ | VNMF3131C174TU | ||
| VNMC3131C182TU | VNMF3131C229TE | ||
| VNMC3131C223TE | VNMF3131C229TJ | ||
| VNMC3131C223TJ | VNMF3131C229TU | ||
| VNMC3131C223TU | VNMF3131C97TE | ||
| VNMC3131C90TE | VNMF3131C97TJ | ||
| VNMC3131C90TJ | VNMF3131C97TU | ||
| VNMC3131C90TU | VNMF3428C173TE | ||
| VNMC3428C207TE | VNMF3428C173TJ | ||
| VNMC3428C207TJ | VNMF3428C173TU | ||
| VNMC3428C207TU | VNMF3434C174TE | ||
| VNMC3434C182TE | VNMF3434C174TJ | ||
| VNMC3434C182TJ | VNMF3434C174TU | ||
| VNMC3434C182TU | VNMF3434C229TE | ||
| VNMC3434C223TE | VNMF3434C229TJ | ||
| VNMC3434C223TJ | VNMF3434C229TU | ||
| VNMC3434C223TU | VNMF3434C59TE | ||
| VNMC3434C52TE | VNMF3434C59TJ | ||
| VNMC3434C52TJ | VNMF3434C59TU | ||
| VNMC3434C52TU | VNMF3434C97TE | ||
| VNMC3434C90TE | VNMF3434C97TJ | ||
| VNMC3434C90TJ | VNMF3434C97TU | ||
| VNMC3434C90TU | VNMF3731C173TE | ||
| VNMC3731C207TE | VNMF3731C173TJ | ||
| VNMC3731C207TJ | VNMF3731C173TU | ||
| VNMC3731C207TU | VNMF3737C174TE | ||
| VNMC3737C182TE | VNMF3737C174TJ | ||
| VNMC3737C182TJ | VNMF3737C174TU | ||
| VNMC3737C182TU | VNMF3737C229TE | ||
| VNMC3737C223TE | VNMF3737C229TJ | ||
| VNMC3737C223TJ | VNMF3737C229TU | ||
| VNMC3737C223TU | VNMF3737C59TE | ||
| VNMC3737C52TE | VNMF3737C59TJ | ||
| VNMC3737C52TJ | VNMF3737C59TU | ||
| VNMC3737C52 | VNMF3737C97TE | ||
| VNMC3737C90TE | VNMF3737C97TJ | ||
| VNMC3737C90TJ | VNMF3737C97TU | ||
| VNMC3737C90TU | VNMF4034C185TE | ||
| VNMC4034C200TE | VNMF4034C185TJ | ||
| VNMC4034C200TJ | VNMF4034C185TU | ||
| VNMC4034C200TU | VNMF4040C103TE | ||
| VNMC4040C175TE | VNMF4040C103TJ | ||
| VNMC4040C175TJ | VNMF4040C103TU | ||
| VNMC4040C175TU | VNMF4040C183TE | ||
| VNMC4040C218TE | VNMF4040C183TJ | ||
| Stent Graft | VNMC4040C218TJ | Stent Graft | VNMF4040C183TU |
| VNMC4040C218TU | VNMF4040C223TE | ||
| VNMC4040C55TE | VNMF4040C223TJ | ||
| VNMC4040C55TJ | VNMF4040C223TU | ||
| VNMC4040C55TU | VNMF4040C62TE | ||
| VNMC4040C95TE | VNMF4040C62TJ | ||
| VNMC4040C95TJ | VNMF4040C62TU | ||
| VNMC4040C95TU | VNMF4337C185TE | ||
| VNMC4337C200TE | VNMF4337C185TJ | ||
| VNMC4337C200TJ | VNMF4337C185TU | ||
| VNMC4337C200TU | VNMF4343C103TE | ||
| VNMC4343C175TE | VNMF4343C103TJ | ||
| VNMC4343C175TJ | VNMF4343C103TU | ||
| VNMC4343C175TU | VNMF4343C183TE | ||
| VNMC4343C218TE | VNMF4343C183TJ | ||
| VNMC4343C218TJ | VNMF4343C183TU | ||
| VNMC4343C218TU | VNMF4343C223TE | ||
| VNMC4343C55TE | VNMF4343C223TJ | ||
| VNMC4343C55TJ | VNMF4343C223TU | ||
| VNMC4343C55TU | VNMF4343C62TE | ||
| VNMC4343C95TE | VNMF4343C62TJ | ||
| VNMC4343C95TJ | VNMF4343C62TU | ||
| VNMC4343C95TU | VNMF4640C185TE | ||
| VNMC4640C200TE | VNMF4640C185TJ | ||
| VNMC4640C200TJ | VNMF4640C185TU | ||
| VNMC4640C200TU | VNMF4646C103TE | ||
| VNMC4646C175TE | VNMF4646C103TJ | ||
| VNMC4646C175TJ | VNMF4646C103TU | ||
| VNMC4646C175TU | VNMF4646C183TE | ||
| VNMC4646C218TE | VNMF4646C183TJ | ||
| VNMC4646C218TJ | VNMF4646C183TU | ||
| VNMC4646C218TU | VNMF4646C223TE | ||
| VNMC4646C55TE | VNMF4646C223TJ | ||
| VNMC4646C55TJ | VNMF4646C223TU | ||
| VNMC4646C55TU | VNMF4646C62TE | ||
| VNMC4646C95TE | VNMF4646C62TJ | ||
| VNMC4646C95TJ | VNMF4646C62TU |
Medtronic International, Ltd. initiated the voluntary recall of the above-mentioned specific lots/batches of Medtronic Valiant Naviation™ Thoracic Stent Graft System. The recall is being initiated in response to information identified in the Valiant Evo Global Clinical Program, which studied the performance of the above-mentioned product. A total of 110 subjects were enrolled in the Valiant Evo Global Clinical Program. The information received indicated that there were three (3) subjects with stent fractures of which (2) confirmed Type IIIb endoleaks, and seven (7) core lab analysis findings showing stent ring enlargement. Type IIIb endoleaks, if untreated, can potentially lead to aneurysm rupture.
In light of the foregoing, all concerned healthcare professional, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Medtronic Valiant Naviation™ Thoracic Stent Graft System.
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.