CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report
The Treo Abdominal Stent-graft System recalled by Bolton Medical
Bolton Medical is recalling The Treo Abdominal Stent-graft System (Treo) consists of four types of implants, distributed nationwide in the US. The recall was initiated on 3 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1689-2023
- FDA event ID
- 92252
- Recalling firm
- Bolton Medical, Sunrise, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 May 2023
- FDA classified
- 6 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 May 2023 | Recall initiated by company | |
| 6 Jun 2023 | Classified by FDA | +34 days |
| 14 Jun 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the incorrect size stent-graft than the printed carton label.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
Questions about this recall
Why was it recalled?
Potential for the incorrect size stent-graft than the printed carton label.
Which lots are affected?
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)
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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