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TREO Abdominal Stent-Graft System recallZ-1689-2023 · Bolton Medical Inc. · initiated May 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bolton Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1689-2023
Status
Open, Classified
Initiated by the company
May 3, 2023
Posted by the FDA
Jun 6, 2023
Recalling firm
Bolton Medical Inc.
Quantity
216 units
Product code
MIH
FDA submissions
P190015
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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)

Devices named in this recall

24 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

49 devices cleared under P190015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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