Class II Recall

The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr

Summary

The FDA issued a Class II for The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, by Bolton Medical Inc.. Reason: Potential for the incorrect size stent-graft than the printed carton label..

Details

Source

Device Recall

External ID

Z-1689-2023

Action Date

2023-06-14

Status

Ongoing

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.

Lot/Code Info: 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)

Quantity Affected: 216 units

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-03

Company

Bolton Medical Inc.

Sunrise, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bolton Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Bolton Medical Inc. have FDA actions?

Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1689-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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