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RelayPro Thoracic Stent-Graft System recallZ-0998-2023 · Bolton Medical Inc. · initiated Dec 20, 2022

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

The product may be shorter than packaging indicates

FDA root cause category: Labeling Change Control

What the company is doing

On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.

Recall details

Recall number
Z-0998-2023
Status
Open, Classified
Initiated by the company
Dec 20, 2022
Posted by the FDA
Jan 19, 2023
Recalling firm
Bolton Medical Inc.
Quantity
640 units
Product code
MIH
Distribution
Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

Product description

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

Code information (models, lots, serial numbers)

Show the full code information (15k characters)

UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4-24-099-24S, Lot Numbers: B220323028, B211222140; UDI/DI 00843576150423, REF 28-N4-24-099-24U, Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035; UDI/DI 00843576100961, REF 28-N4-24-159-24S, Lot Numbers: B220104035, B220824113, B210612293, B220201173; UDI/DI 00843576150553, REF 28-N4-24-159-24U, Lot Numbers: 2202090215, 2202090293; UDI/DI 00843576101227, REF 28-N4-24-259-24S, Lot Numbers: B220210257, B220210257; UDI/DI 00843576150812, REF 28-N4-24-259-24U, Lot Numbers: 2210110048, 2210110049, 2210100193; UDI/DI 00843576100848, REF 28-N4-26-104-26S, Lot Numbers: B220226088, B220414055; UDI/DI 00843576150430, REF 28-N4-26-104-26U, Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202; UDI/DI 00843576100978, REF 28-N4-26-164-26S, Lot Numbers: B220316171, B210927313, B210602367, B220303176, B220316275, B220204220, B220210181, B220210141, B211215127, B220203121; UDI/DI 00843576150560, REF 28-N4-26-164-26U, Lot Numbers: 2110130276, 2203030136, 2203040029, 2206140190, 2202280430, 2203030197, 2202020185, 2202090218, 2202100235; UDI/DI 00843576150690, REF 28-N4-26-204-26U, Lot Numbers: 2201150114, 2204150063, 2206130239; UDI/DI 00843576100855, REF 28-N4-28-104-28S, Lot Numbers: B220323030, B220323295, B221024139, B221026118, B221024275; UDI/DI 00843576150447, REF 28-N4-28-104-28U, Lot Numbers: 2108090034, 2206140194, 2112170035, 2202100079, 2202110166, 2202160141; UDI/DI 00843576150935, REF 28-N4-28-164-24U, Lot Numbers: 2202160143, 2202160143, 220614019; UDI/DI 00843576100985, REF 28-N4-28-164-28S, Lot Numbers: 2202150157, B210713325, B211019291, B211218042, B211217126, B211228051, B211228183, B211019294, B220302187, B220308234, B220308196, B220315291, B220315290, B220316085, B220224046, B211215130, B220211180, B220215104, B220215116, B211218039, B220215116; UDI/DI 00843576150577, REF 28-N4-28-164-28U, Lot Numbers: 2202140139, 2203160088, 2203110300, 2208190099, 2203110300, 2208230038; UDI/DI 00843576101449, REF 28-N4-28-204-24S, Lot Numbers: B220216144; UDI/DI 00843576151031, REF 28-N4-28-204-24U, Lot Numbers: 2203040078, 2203040076; UDI/DI 00843576101111, REF 28-N4-28-204-28S, Lot Numbers: B220222108, B220222103, B220222101, B220216186, B220315302; UDI/DI 00843576150706, REF 28-N4-28-204-28U, Lot Numbers: 2203140261, 2210260120; UDI/DI 00843576100862, REF 28-N4-30-104-30S, Lot Numbers: B220222073, B220613221, B220316226, UDI/DI 00843576150454, REF 28-N4-30-104-30U, Lot Numbers: 2202150087, 2108110152, 2108110159, 2108140005, 2108110132, 2202160183, 2202150087, 2202280426, 2110180211, 2206130118, 2206130220, 2206130222, 2108240015; UDI/DI 00843576101357, REF 28-N4-30-164-26S, Lot Numbers: B220316227, B220224140, B220224216, B220223287, B220224044, B220222297, B220225423; UDI/DI 00843576150942, REF 28-N4-30-164-26U, Lot Numbers: 2203040072, 2110130019, 2110130017, 2203040073, 2110190312, 2208250041, 2112220164, 2201210010, 2202050219, 2202030151, 2210110302, 2205210093; UDI/DI 00843576100992, REF 28-N4-30-164-30S, Lot Numbers: B220324178, B220324178, B220324163, B211012014; UDI/DI 00843576150584, REF 28-N4-30-164-30U, Lot Numbers: 2203010234, 2202230316, 2202250014, 2202280425, 2202180529, 2202220074, 2202220072, 2202220069, 2202180529, 2202220074, 2202220072, 2202220069, 2203020201, 2206130228, 2202140234; UDI/DI 00843576101456, REF 28-N4-30-209-26S, Lot Numbers: B220316255; UDI/DI 00843576151048, REF 28-N4-30-209-26U, Lot Numbers: 2112140027, 2112130022, 2202160146, 2202150163, 2202160145, 2203160257, 2208250012, 2201180076, 2203160257, 2208240034; UDI/DI 00843576101128, REF 28-N4-30-209-30S, Lot Numbers: B220326008, B220222333; UDI/DI 00843576150713, REF 28-N4-30-209-30U, Lot Numbers: 2203160252, 2202220110, 2202220113, 2203160253, 2112210090, 2201040111, 2201180074, 2202140257, 2202100239, 2202110347; UDI/DI 00843576101258, REF 28-N4-30-259-30S, Lot Numbers: B220215153; UDI/DI 00843576100879, REF 28-N4-32-104-32S, Lot Numbers: B220216231, B221021262, B220324319; UDI/DI 00843576150461, REF 28-N4-32-104-32U, Lot Numbers: 2108120046, 2107140315, 2202180555, 2202160240, 2202170062, 2107260368, 2107240008, 2112170233, 2202190002, 2202180531, 2202180555, 2202190002, 2107260364, 2112270017, 2202040221; UDI/DI 00843576101364, REF 28-N4-32-164-28S, Lot Numbers: B220324327, B220822175, B220824051, B220823128, B220824185, B220824144, B211216067, B220325018, B220324175, B220324176, B220825153, B211215259, B220324175, B220324176, B220823156, B220823157; UDI/DI 00843576150959, REF 28-N4-32-164-28U, Lot Numbers: 2203230306, 2210210006, 2210260127, 2202230291, 2202230295; UDI/DI 00843576101005, REF 28-N4-32-164-32S, Lot Numbers: B220325138, B220323296, B220323298, B220613231, B211211183, B211214172, B211211162; UDI/DI 00843576150591, REF 28-N4-32-164-32U, Lot Numbers: 2203250141, 2203230297, 2110060132, 2203030284, 2208240048, 2208250009, 2210250032, 2203080200, 2112110095, 2204010186, 2210250296; UDI/DI 00843576101463, REF 28-N4-32-209-28S, Lot Numbers: B220323320; UDI/DI 00843576151055, REF 28-N4-32-209-28U, Lot Numbers: 2202020166, 2202180572, 2112150321, 2112110166, 2112110165, 2202280418, 2205250253; UDI/DI 00843576101135, REF 28-N4-32-209-32S, Lot Numbers: B220324197, B211214116, B220222117, B220222117; UDI/DI 00843576150720, REF 28-N4-32-209-32U, Lot Numbers: 2203230299, 2204090207, 2112140173, 2208250166, 2208230272; UDI/DI 00843576101562, REF 28-N4-32-259-28S, Lot Numbers: B211012003; UDI/DI 00843576151154, REF 28-N4-32-259-28U, Lot Numbers: 2206130123; UDI/DI 00843576150478, REF 28-N4-34-109-34U, Lot Numbers: 2203080004, 2203100247, 2108210088, 2109030355, 2203080007, 2112210087, 2112210085, 2210110299, 2112110082, 2203080003, 2206130241; UDI/DI 00843576101371, REF 28-N4-34-154-30S, Lot Numbers: B210608025, B211213134, B211214113, B211028048, B211101323, B211220050, B211221096, B220314244; UDI/DI 00843576150966, REF 28-N4-34-154-30U, Lot Numbers: 2203040077, 2203040075, 2204040345, 2110040246, 2202240217, 2204120411, 2112180054, 2112200048, 2210120224, 2202050011; UDI/DI 00843576101012, REF 28-N4-34-154-34S, Lot Numbers: B211221131, B211220039, B210610038; UDI/DI 00843576150607, REF 28-N4-34-154-34U, Lot Numbers: 2203080204, 2202220094, 2109070357, 2109040003, 2108280016, 2107300166, 2107300158, 2202220127, 2202220104, 2202220129, 2109040002, 2112200021, 2112210095, 2201070130, 2202260034, 2202220096, 2202220075, 2202220079, 2202220138, 2202220102, 2201070146, 2202220075, 2202220138, B220315087; UDI/DI 00843576151062, REF 28-N4-34-209-30U, Lot Numbers: 2205250147, 2112200052, 2201190027, 2201180135, 2201310004; UDI/DI 00843576101142, REF 28-N4-34-209-34S, Lot Numbers: B211214294, B220324009, B220324165, B220324181, B220326025, B220324181, B211214174, B220325013, B220329320; UDI/DI 00843576150737, REF 28-N4-34-209-34U, Lot Numbers: 2210260199, 2210260201, 2210260198, 2210260200, 2210260126, 2210260197, 2210260207, 2203090075, 2203100243, 2203250143, 2206140097; UDI/DI 00843576170155, REF 28-N4-34-210-44U, Lot Numbers: 2208240124; UDI/DI 00843576101272, REF 28-N4-34-259-34S, Lot Numbers: B211222139; UDI/DI 00843576150867, REF 28-N4-34-259-34U, Lot Numbers: 2210100114; UDI/DI 00843576100893, REF 28-N4-36-109-36S, Lot Numbers: B211213218, B221007301, B211215203, B220226036, B220228230, B220228434, B220322215, UDI/DI 00843576150485, REF 28-N4-36-109-36U, Lot Numbers: 2107150330, 2107210144, 2107150333, 2112160106; UDI/DI 00843576101388, REF 28-N4-36-154-32S, Lot Numbers: B220825195, B220316259, B220822023, B211221094; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202140171, 2203100002, 2110060302, 2202170251, 2203080225, 2203080362, 2203030299, 2112100338, 2112150158, 2112150159, 2202150132, 2202140062, 2201200119, 2202140062; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202120091; UDI/DI 00843576101029, REF 28-N4-36-154-36S, Lot Numbers: B220324164, B211217046, B220825165, B211217043, B220420031, B220415060, B220420032, B220419247; UDI/DI 00843576150614, REF 28-N4-36-154-36U, Lot Numbers: 2202140142, 2202140222, 2202140142, 2202120084, 2108040300, 2108100279, 2110120294, 2202250085, 2204200029, 2204190245, 2204140198, 2204180291, 2201200081; UDI/DI 00843576101487, REF 28-N4-36-199-32S, Lot Numbers: B220420141, B220824035, B220823266, B211217230, B220420142; UDI/DI 00843576151079, REF 28-N4-36-199-32U, Lot Numbers: 2112140115, 2202160005, 2202160147, 2202150173, 2202160062, 2202160192, 2202190003, 2202220342, 2201180071, 2201210202, 2202150173, 2202160192, 2202190003, 2202160147, 2201310240; UDI/DI 00843576101159, REF 28-N4-36-199-36S, Lot Numbers: B220325145, B220316278, B220614146, B220812095, B220824139; UDI/DI 00843576150744, REF 28-N4-36-199-36U, Lot Numbers: 2202160190, 2202170035, 2203030285, 2203250159, 2204200134, 2203080251, 2203020257, 2203040068, 2203160254, 2203160313, 2112180048, 2112200054, 2112200042, 2202120166, 2204200137, 2204200132, 2202120166, 2202170035; UDI/DI 00843576151178, REF 28-N4-36-259-32U, Lot Numbers: 2102240015, 2201170287; UDI/DI 00843576101289, REF 28-N4-36-259-36S, Lot Numbers: B220412367, B220226086; UDI/DI 00843576150492, REF 28-N4-38-109-38U, Lot Numbers: 2201290084, 2107220127, 2112010077, 2107220126; UDI/DI 00843576101395, REF 28-N4-38-154-34S, Lot Numbers: B220329299, B220418293; UDI/DI 00843576150980, REF 28-N4-38-154-34U, Lot Numbers: 2201210011, 2204210129, 2204060407, 2204220290, 2112130021, 2201290305; UDI/DI 00843576101036, REF 28-N4-38-154-38S, Lot Numbers: B220329318, B220420115, B211215133, B211215143, B211215134, B211227031, B220823037; UDI/DI 00843576150621, REF 28-N4-38-154-38U, Lot Numbers: 2110130259, 2201260405, 2110130263, 2110130261, 2110130262, 2204210143, 2208230039, 2208250172, 2201200092, 2201200099, 2201210068, 2201260344, 2205060274; UDI/DI 00843576101494, REF 28-N4-38-199-34S, Lot Numbers: B220414211; UDI/DI 00843576151086, REF 28-N4-38-199-34U, Lot Numbers: 2203030169, 2210260129, 2206130122, 2112220144, 2112150208, 2201180083, 2201180079, 2201180132, 2201210298; UDI/DI 00843576101166, REF 28-N4-38-199-38S, Lot Numbers: B220411209, B220823257, B220614191, B220823260; UDI/DI 00843576150751, REF 28-N4-38-199-38U, Lot Numbers: 2203080257, 2201210100, 2201210117, 2201210186, 2201210057, 2201270226, 2208230274, 2208230124, 2208240033, 2208230258, 2208220167, 2208250078, 2208240184, 2208250152, 2201210157, 2201250164; UDI/DI 00843576101593, REF 28-N4-38-259-34S, Lot Numbers: B220315384; UDI/DI 00843576151185, REF 28-N4-38-259-34U, Lot Numbers: 2108260329; UDI/DI 00843576101296, REF 28-N4-38-259-38S, Lot Numbers: B210609044, B211214297, B220824031; UDI/DI 00843576150881, REF 28-N4-38-259-38U, Lot Numbers: 2203080242, 2108040320, 2204110222, 2204200258; UDI/DI 00843576100916, REF 28-N4-40-114-40S, Lot Numbers: B211220015; UDI/DI 00843576101401, REF 28-N4-40-154-36S, Lot Numbers: B220212187, B211218056, B211221089, B220214225, B220328369; UDI/DI 00843576150997, REF 28-N4-40-154-36U, Lot Numbers: 2203240199, 2203250146, 2201210024, 2201210021, 2201210027, 2201310002; UDI/DI 00843576101043, REF 28-N4-40-154-40S, Lot Numbers: B220328261, B220329007, B220328341, B220124254, B211227044, B220301024; UDI/DI 00843576150638, REF 28-N4-40-154-40U, Lot Numbers: 2201200112, 2205180204, 2204220151, 2204210111, 2204200034, 2204090201, 2201180080, 2201210330, 2203010010, 2204230122, 2201250163; UDI/DI 00843576101500, REF 28-N4-40-204-36S, Lot Numbers: B220324328, B220316279; UDI/DI 00843576151093, REF 28-N4-40-204-36U, Lot Numbers: 2112130223, 2210260205, 2204220084, 2201310010, 2201280055, 2204200217, 2204220085, 2204200140, 2210120145, 2210260204, 2201220095; UDI/DI 00843576101173, REF 28-N4-40-204-40S, Lot Numbers: B220328304, B220328305, B220613305; UDI/DI 00843576150768, REF 28-N4-40-204-40U, Lot Numbers: 2203030296, 2204200040, 2203080217, 2201150117, 2201220082, 2204210012, 2204210125, 2201220134, 2201280513, 2201270355, 2204200039; UDI/DI 00843576101609, REF 28-N4-40-259-36S, Lot Numbers: B220824044, B220824036; UDI/DI 00843576151192, REF 28-N4-40-259-36U, Lot Numbers: 2204200222; UDI/DI 00843576150898, REF 28-N4-40-259-40U, Lot Numbers: 2204190260; UDI/DI 00843576100923, REF 28-N4-42-114-42S, Lot Numbers: B220321140, B220404334; UDI/DI 00843576150515, REF 28-N4-42-114-42U, Lot Numbers: 2203160312, 2204040417, 2203160251, 2203220286; UDI/DI 00843576101418, REF 28-N4-42-159-38S, Lot Numbers: B211012054, B220325029, B211012055, B220321152, B211012056, B220328370, B220404378, B220402106; UDI/DI 00843576101050, REF 28-N4-42-159-42S, Lot Numbers: B220316277, B220406080, B220402047, B211009014, B220414056, B220406068; UDI/DI 00843576150645, REF 28-N4-42-159-42U, Lot Numbers: 2110140278, 2110140277, 2110140280, 2204210144, 2204210162, 2204210161, 2201310162, 2201310237, 2202010186, 2204210146, 2204200119; UDI/DI 00843576151109, REF 28-N4-42-204-38U, Lot Numbers: 2108140131, B220322396, 2107280013; UDI/DI 00843576100930, REF 28-N4-44-114-44S, Lot Numbers: B220222271, B220222274; UDI/DI 00843576150522, REF 28-N4-44-114-44U, Lot Numbers: 2206140189, 2202220098; UDI/DI 00843576101425, REF 28-N4-44-164-40S, Lot Numbers: B220324203; UDI/DI 00843576101067, REF 28-N4-44-164-44S, Lot Numbers: B211011231, B211006018; UDI/DI 00843576150652, REF 28-N4-44-164-44U, Lot Numbers: 2202030148, 2202040349, 2202040352, 2202040347, 2208190235; UDI/DI 00843576101524, REF 28-N4-44-209-40S, Lot Numbers: B220824003; UDI/DI 00843576151116, REF 28-N4-44-209-40U, Lot Numbers: 2202020151, 2206140102, 2208250013, 2202050009, 2202100078; UDI/DI 00843576101197, REF 28-N4-44-209-44S, Lot Numbers: B220328360, B220614195, B220328357, B220328351; UDI/DI 00843576150782, REF 28-N4-44-209-44U, Lot Numbers: 2203030286, 2107300026; UDI/DI 00843576101432, REF 28-N4-46-164-42S, Lot Numbers: B220328378, B221021036, B220325147; UDI/DI 00843576151024, REF 28-N4-46-164-42U, Lot Numbers: 2110050160, 2202040376; UDI/DI 00843576101531, REF 28-N4-46-209-42S, Lot Numbers: B220329306, B221025297, B220326018; UDI/DI 00843576151123, REF 28-N4-46-209-42U, Lot Numbers: 2110180197, 2202040375; UDI/DI 00843576101203, REF 28-N4-46-209-46S, Lot Numbers: B220329254, B220322230; UDI/DI 00843576150799, REF 28-N4-46-209-46U, Lot Numbers: 2110090005, 2202100283, 2202010117; UDI/DI 00843576151222, REF 28-N4-46-259-42U, Lot Numbers: 2107200052;

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91292).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page