Bolton Medical Inc.: 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 flow.

Recall number

Z-1689-2023

Recalling firm

Bolton Medical Inc.

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 flow.

Status

Open, Classified

Initiated

2023-05-03

Posted

2023-06-06

Terminated

not on file

Reason

Potential for the incorrect size stent-graft than the printed carton label.

Root cause

Process control

Action

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.

Quantity

216 units

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

["P190015"]

Product code

MIH

Firm FEI

1000135961

Firm city

Sunrise

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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