TREO Abdominal Stent-Graft (Bolton) – Incorrect Size (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and fl
Brand
Bolton Medical Inc.
Lot Codes / Batch Numbers
a. GTIN Number: 00843576151963, Catalog Number (Lot Number): 28-S2-13-080U (2104270154), b. GTIN Number: 00843576151994, Catalog Number (Lot Number): 28-L2-13-080U (2104260081, 2104260083, 2104260082, 2104260085, 2104260084, 2104260087), c. GTIN Number: 00843576152007, Catalog Number: 28-L2-15-080U, Lot Number: 2104120114, d. GTIN Number: 00843576152038, Catalog Number (Lot Number): 28-L2-24-080U (2104230422, 2104230421), e. GTIN Number: 00843576152076, Catalog Number (Lot Number): 28-L2-15-100U (2104170055, 2104170053), f. GTIN Number: 00843576152083, Catalog Number (Lot Number): 28-L2-17-100U (2104230448, 2104230449, 2104230444, 2104230459, 2104230450, 2104230447, 2104230446, 2104230445, 2104230443, 2104230442, 2104230441, 2104230437, 2104230435), g. GTIN Number: 00843576152090, Catalog Number (Lot Number): 28-L2-20-100U (2104230399, 2104230394, 2104230391, 2104230392, 2104230395, 2104230401, 2104230398, 2104230403, 2104230406, 2104230404, 2104230409, 2104230408, 2104230412, 2104230411, 2104230400, 2104230396, 2104230390, 2104230405, 2104230402, 2104230407), h. GTIN Number: 00843576152137, Catalog Number (Lot Number): 28-L2-13-120U (2104230470, 2104230469, 2104230468, 2104230472, 2104230471), i, GTIN Number: 00843576152144, Catalog Number (Lot Number): 28-L2-15-120U (2104230365, 2104230371, 2104230370, 2104230366, 2104230364, 2104230363, 2104230372, 2104230369, 2104230368, 2104230367), j. GTIN Number: 00843576152229, Catalog Number (Lot Number): 28-L2-17-140U (2104270162, 2104260077, 2104260078), k. GTIN Number: 00843576152342, Catalog Number (Lot Number): 28-B2-24-080U (2104230229, 2104230230, 2104230233, 2104230236, 2104230232, 2104230226, 2104230235, 2104230244, 2104230228, 2104230231, 2104230234, 2104230227), l. GTIN Number: 00843576152359, Catalog Number (Lot Number): 28-B2-26-080U (2104230262, 2104230258, 2104230275, 2104230260, 2104230264, 2104230259, 2104230266, 2104230263, 2104230272, 2104230257, 2104230261, 2104230273, 2104230274, 2104230265, 2104230270, 2104230281, 2104230268, 2104230267, 2104230269, 2104230278, 2104230279, 2104230280, 2104230271), m. GTIN Number: 00843576152366, Catalog Number (Lot Number): 28-B2-28-080U (2104230124, 2104230138, 2104230135, 2104230143, 2104230136, 2104230139, 2104230125, 2104230142), n. GTIN Number: 00843576152373, Catalog Number (Lot Number): 28-B2-30-080U (2104230187, 2104230196, 2104230199, 2104230186, 2104230184, 2104230185, 2104230200, 2104230201, 2104230193, 2104230198, 2104230192, 2104230191, 2104230194, 2104230197, 2104230183, 2104230182, 2104230189, 2104230188, 2104230195, 2104230190), o. GTIN Number: 00843576152441, Catalog Number (Lot Number): 28-B2-28-100U (2104230169, 2104230168, 2104230170, 2104230171, 2104230154, 2104230164, 2104230165, 2104230166, 2104230167), p. GTIN Number: 00843576152441, Catalog Number (Lot Number): 28-B2-28-100U (2104230169, 2104230168, 2104230170, 2104230171, 2104230154, 2104230164, 2104230165, 2104230166, 2104230167), q. GTIN Number: 00843576152458, Catalog Number (Lot Number): 28-B2-30-100U (2104260091), r. GTIN Number: 00843576152472, Catalog Number (Lot Number): 28-B2-36-100U (2104170130, 2104170128, 2104170132, 2104170133, 2104170131, 2104170134), s. GTIN Number: 00843576152595, Catalog Number (Lot Number): 28-C2-26-040U (2104230316, 2104230314), t. GTIN Number: 00843576152601, Catalog Number (Lot Number): 28-C2-28-040U (2104230337, 2104230336), u. GTIN Number: 00843576152618, Catalog Number (Lot Number): 28-C2-30-040U (2104230347), v. GTIN Number: 00843576152656, Catalog Number (Lot Number): 28-C2-22-055U (2104170101, 2104170100), w. GTIN Number: 00843576152663, Catalog Number (Lot Number): 28-C2-24-055U (2101130271), x. GTIN Number: 00843576152670, Catalog Number (Lot Number): 28-C2-26-055U (2104170180), y. GTIN Number: 00843576152762, Catalog Number (Lot Number): 28-C2-28-070U (2104230342, 2104230341, 2104230339, 2104230340), z. GTIN Number: 08436045396747, Catalog Number (Lot Number): 28-B2-28-080S (B210423141, B210423137), aa. GTIN Number: 08436045396938, Catalog Number (Lot Number): 28-B2-36-120S (B201112209, B210423202), bb. GTIN Number: 08436045396976, Catalog Number (Lot Number): 28-C2-26-040S (B210423317, B210423318, B210423319), cc. GTIN Number: 08436045396983, Catalog Number (Lot Number): 28-C2-28-040S (B210423338, B210423335, B210824336), dd. GTIN Number: 08436045396990, Catalog Number (Lot Number): 28-C2-30-040S (B210423346, B210423348, B210423345), ee. GTIN Number: 08436045397041, Catalog Number (Lot Number): 28-C2-24-055S (B210423216, B210423215, B210423214), ff. GTIN Number: 08436045397126, Catalog Number (Lot Number): 28-C2-24-070S (B210423305, B210423304, B210423306, B210423303, B210423307), gg. GTIN Number: 08436045397133, Catalog Number (Lot Number): 28-C2-26-070S (B210423328, B210423330, B210423331, B210423333, B210423332), hh. GTIN Number: 08436045397195, Catalog Number (Lot Number): 28-L2-11-080S (B210123087), ii. GTIN Number: 08436045397201, Catalog Number (Lot Number): 28-L2-13-080S (B210426086, B210426080, B210426079), jj. GTIN Number: 08436045397249, Catalog Number (Lot Number): 28-L2-24-080S (B210423424, B210423425), kk. GTIN Number: 08436045397263, Catalog Number (Lot Number): 28-L2-11-100S (B210109120), ll. GTIN Number: 08436045397287, Catalog Number (Lot Number): 28-L2-15-100S (B210417056, B210417054), mm. GTIN Number: 08436045397294, Catalog Number (Lot Number): 28-L2-17-100S (B210423433), nn. GTIN Number: 08436045397430, Catalog Number (Lot Number): 28-L2-17-140S (B210423477), oo. GTIN Number: 08436045397447, Catalog Number (Lot Number): 28-L2-20-140S (B210427160, B210427167), pp. GTIN Number: 08436045397485, Catalog Number (Lot Number): 28-L2-13-160S (B210417186), qq. GTIN Number: 08436045397553, Catalog Number (Lot Number): 28-S2-13-080S (B210427155, B210427156, B210427157), rr. GTIN Number: 08436045397577, Catalog Number (Lot Number): 28-A1-22-100S (B210413330, B210413329), ss. GTIN Number: 08436045397584, Catalog Number (Lot Number): 28-A1-24-100S (B210413288, B210413292, B210413291, B210413290), tt. GTIN Number: 08436045397591, Catalog Number (Lot Number): 28-A1-26-100S (B210419042, B210419039, B210419040), uu. GTIN Number: 08436045397607, Catalog Number (Lot Number): 28-A1-28-100S (B210419093), vv. GTIN Number: 08436045397621, Catalog Number (Lot Number): 28-A1-33-100S (B200305246, B210413345), ww. GTIN Number: 08436045397638, Catalog Number (Lot Number): 28-A1-36-100S (B210419171, B210414006), xx. No GTIN, Catalog Number (Lot Number): 28-CMP-2734-L4 (2104290063), 28-CMP-2802-L1 (2104290061), 28-CMP-2789-L2 (2104290076), 28-CMP-2802-L2 (2104290066)
Products Sold
a. GTIN Number: 00843576151963, Catalog Number (Lot Number): 28-S2-13-080U (2104270154); b. GTIN Number: 00843576151994, Catalog Number (Lot Number): 28-L2-13-080U (2104260081, 2104260083, 2104260082, 2104260085, 2104260084, 2104260087); c. GTIN Number: 00843576152007, Catalog Number: 28-L2-15-080U, Lot Number: 2104120114; d. GTIN Number: 00843576152038, Catalog Number (Lot Number): 28-L2-24-080U (2104230422, 2104230421); e. GTIN Number: 00843576152076, Catalog Number (Lot Number): 28-L2-15-100U (2104170055, 2104170053); f. GTIN Number: 00843576152083, Catalog Number (Lot Number): 28-L2-17-100U (2104230448, 2104230449, 2104230444, 2104230459, 2104230450, 2104230447, 2104230446, 2104230445, 2104230443, 2104230442, 2104230441, 2104230437, 2104230435); g. GTIN Number: 00843576152090, Catalog Number (Lot Number): 28-L2-20-100U (2104230399, 2104230394, 2104230391, 2104230392, 2104230395, 2104230401, 2104230398, 2104230403, 2104230406, 2104230404, 2104230409, 2104230408, 2104230412, 2104230411, 2104230400, 2104230396, 2104230390, 2104230405, 2104230402, 2104230407); h. GTIN Number: 00843576152137, Catalog Number (Lot Number): 28-L2-13-120U (2104230470, 2104230469, 2104230468, 2104230472, 2104230471); i; GTIN Number: 00843576152144, Catalog Number (Lot Number): 28-L2-15-120U (2104230365, 2104230371, 2104230370, 2104230366, 2104230364, 2104230363, 2104230372, 2104230369, 2104230368, 2104230367); j. GTIN Number: 00843576152229, Catalog Number (Lot Number): 28-L2-17-140U (2104270162, 2104260077, 2104260078); k. GTIN Number: 00843576152342, Catalog Number (Lot Number): 28-B2-24-080U (2104230229, 2104230230, 2104230233, 2104230236, 2104230232, 2104230226, 2104230235, 2104230244, 2104230228, 2104230231, 2104230234, 2104230227); l. GTIN Number: 00843576152359, Catalog Number (Lot Number): 28-B2-26-080U (2104230262, 2104230258, 2104230275, 2104230260, 2104230264, 2104230259, 2104230266, 2104230263, 2104230272, 2104230257, 2104230261, 2104230273, 2104230274, 2104230265, 2104230270, 2104230281, 2104230268, 2104230267, 2104230269, 2104230278, 2104230279, 2104230280, 2104230271); m. GTIN Number: 00843576152366, Catalog Number (Lot Number): 28-B2-28-080U (2104230124, 2104230138, 2104230135, 2104230143, 2104230136, 2104230139, 2104230125, 2104230142); n. GTIN Number: 00843576152373, Catalog Number (Lot Number): 28-B2-30-080U (2104230187, 2104230196, 2104230199, 2104230186, 2104230184, 2104230185, 2104230200, 2104230201, 2104230193, 2104230198, 2104230192, 2104230191, 2104230194, 2104230197, 2104230183, 2104230182, 2104230189, 2104230188, 2104230195, 2104230190); o. GTIN Number: 00843576152441, Catalog Number (Lot Number): 28-B2-28-100U (2104230169, 2104230168, 2104230170, 2104230171, 2104230154, 2104230164, 2104230165, 2104230166, 2104230167); p. GTIN Number: 00843576152441, Catalog Number (Lot Number): 28-B2-28-100U (2104230169, 2104230168, 2104230170, 2104230171, 2104230154, 2104230164, 2104230165, 2104230166, 2104230167); q. GTIN Number: 00843576152458, Catalog Number (Lot Number): 28-B2-30-100U (2104260091); r. GTIN Number: 00843576152472, Catalog Number (Lot Number): 28-B2-36-100U (2104170130, 2104170128, 2104170132, 2104170133, 2104170131, 2104170134); s. GTIN Number: 00843576152595, Catalog Number (Lot Number): 28-C2-26-040U (2104230316, 2104230314); t. GTIN Number: 00843576152601, Catalog Number (Lot Number): 28-C2-28-040U (2104230337, 2104230336); u. GTIN Number: 00843576152618, Catalog Number (Lot Number): 28-C2-30-040U (2104230347); v. GTIN Number: 00843576152656, Catalog Number (Lot Number): 28-C2-22-055U (2104170101, 2104170100); w. GTIN Number: 00843576152663, Catalog Number (Lot Number): 28-C2-24-055U (2101130271); x. GTIN Number: 00843576152670, Catalog Number (Lot Number): 28-C2-26-055U (2104170180); y. GTIN Number: 00843576152762, Catalog Number (Lot Number): 28-C2-28-070U (2104230342, 2104230341, 2104230339, 2104230340); z. GTIN Number: 08436045396747, Catalog Number (Lot Number): 28-B2-28-080S (B210423141, B210423137); aa. GTIN Number: 08436045396938, Catalog Number (Lot Number): 28-B2-36-120S (B201112209, B210423202); bb. GTIN Number: 08436045396976, Catalog Number (Lot Number): 28-C2-26-040S (B210423317, B210423318, B210423319); cc. GTIN Number: 08436045396983, Catalog Number (Lot Number): 28-C2-28-040S (B210423338, B210423335, B210824336); dd. GTIN Number: 08436045396990, Catalog Number (Lot Number): 28-C2-30-040S (B210423346, B210423348, B210423345); ee. GTIN Number: 08436045397041, Catalog Number (Lot Number): 28-C2-24-055S (B210423216, B210423215, B210423214); ff. GTIN Number: 08436045397126, Catalog Number (Lot Number): 28-C2-24-070S (B210423305, B210423304, B210423306, B210423303, B210423307); gg. GTIN Number: 08436045397133, Catalog Number (Lot Number): 28-C2-26-070S (B210423328, B210423330, B210423331, B210423333, B210423332); hh. GTIN Number: 08436045397195, Catalog Number (Lot Number): 28-L2-11-080S (B210123087); ii. GTIN Number: 08436045397201, Catalog Number (Lot Number): 28-L2-13-080S (B210426086, B210426080, B210426079); jj. GTIN Number: 08436045397249, Catalog Number (Lot Number): 28-L2-24-080S (B210423424, B210423425); kk. GTIN Number: 08436045397263, Catalog Number (Lot Number): 28-L2-11-100S (B210109120); ll. GTIN Number: 08436045397287, Catalog Number (Lot Number): 28-L2-15-100S (B210417056, B210417054); mm. GTIN Number: 08436045397294, Catalog Number (Lot Number): 28-L2-17-100S (B210423433); nn. GTIN Number: 08436045397430, Catalog Number (Lot Number): 28-L2-17-140S (B210423477); oo. GTIN Number: 08436045397447, Catalog Number (Lot Number): 28-L2-20-140S (B210427160, B210427167); pp. GTIN Number: 08436045397485, Catalog Number (Lot Number): 28-L2-13-160S (B210417186); qq. GTIN Number: 08436045397553, Catalog Number (Lot Number): 28-S2-13-080S (B210427155, B210427156, B210427157); rr. GTIN Number: 08436045397577, Catalog Number (Lot Number): 28-A1-22-100S (B210413330, B210413329); ss. GTIN Number: 08436045397584, Catalog Number (Lot Number): 28-A1-24-100S (B210413288, B210413292, B210413291, B210413290); tt. GTIN Number: 08436045397591, Catalog Number (Lot Number): 28-A1-26-100S (B210419042, B210419039, B210419040); uu. GTIN Number: 08436045397607, Catalog Number (Lot Number): 28-A1-28-100S (B210419093); vv. GTIN Number: 08436045397621, Catalog Number (Lot Number): 28-A1-33-100S (B200305246, B210413345); ww. GTIN Number: 08436045397638, Catalog Number (Lot Number): 28-A1-36-100S (B210419171, B210414006); xx. No GTIN, Catalog Number (Lot Number): 28-CMP-2734-L4 (2104290063), 28-CMP-2802-L1 (2104290061), 28-CMP-2789-L2 (2104290076), 28-CMP-2802-L2 (2104290066)
Bolton Medical Inc. is recalling The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main due to Potential for the incorrect size stent-graft than the printed carton label.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the incorrect size stent-graft than the printed carton label.
Recommended Action
Per FDA guidance
Bolton Medical notified consignees via letter delivered through USPS Certified delivery, on 05/03/2023. Consignees were instructed to examine inventory and quarantine any affected units, complete and return the Acknowledgement Form, arrange for the return of affected units, and maintain a copy of the notification for your records.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026