Z-0997-2023Class II

Relay Pro, Thoracic Stent-Graft System, Ref 28-M4-Xx-Xxx-Xxx

Name: Z-0997-2023 Relay Pro, Thoracic Stent-Graft System, Ref 28-M4-Xx-Xxx-Xxx
Creator: Bolton Medical Inc.
Published: 2022-12-20
License: https://open.fda.gov/license/

Bolton Medical Inc. / initiated 2022-12-20 / Open, Classified / root cause: labeling and UDI

FDA source

Bolton Medical Inc. began a recall of RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX on 2022-12-20. FDA classified it as Class II and gives the reason as "The product may be shorter than packaging indicates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0997-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-20
Posted: 2023-01-19
Recalling firm: Bolton Medical Inc.
Product: Relay Pro, Thoracic Stent-Graft System, Ref 28-M4-Xx-Xxx-Xxx
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: The product may be shorter than packaging indicates
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 129 units
Distribution: Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
Product codes and lots: UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082; UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152; UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116; UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015; UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231; UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239; UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370; UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307; UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146; UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002; UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035; UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097; UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033; UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037; UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191; UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066; UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054; UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090; UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252; UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199; UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276; UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248; UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300; UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313; UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191; UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128; UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235; UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208; UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294; UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072; UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007; UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193; UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194; UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008; UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224; UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298; UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243; UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260; UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098; UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138; UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430; UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359; UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070; UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095; UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418; UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139; UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109; UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290; UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037; UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038; UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130; UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0997-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0997-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19
Z-0998-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)