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Relay®pro thoracic stent-graft system

Official notice

29 May 2026

Last checked

29 May 2026

Critical riskHealth Canada
Watch Bolton Medical

An official Health Canada notice concerns Relay®pro thoracic stent-graft system. Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke. Published 2026-05-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82141

Official notice

2026-05-29

The hazard

Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

28-N4-38-109-38U, 28-N4-40-114-40U, 28-N4-40-204-36U, 28-N4-40-204-40U, 28-N4-46-164-42U, 28-N4-46-259-42U, 28-N4-34-154-34U, 28-N4-40-154-36U, 28-N4-44-209-40U, 28-N4-44-259-40U, 28-N4-32-209-28U, 28-N4-34-154-30U, 28-N4-34-259-34U, 28-N4-36-154-36U, 28-N4-38-154-34U, 28-N4-38-154-38U, 28-N4-42-204-38U, 28-N4-46-164-46U, 28-N4-46-209-42U, 28-N4-32-164-32U, 28-N4-42-204-42U, 28-N4-44-114-44U, 28-N4-44-209-44U, 28-N4-44-259-44U, 28-N4-32-209-32U, 28-N4-34-209-30U, 28-N4-34-209-34U, 28-N4-36-154-32U, 28-N4-36-259-36U, 28-N4-38-199-38U, 28-N4-40-154-40U, 28-N4-42-114-42U, 28-N4-42-159-42U, 28-N4-42-259-42U, 28-N4-44-164-44U, 28-N4-32-104-32U, 28-N4-32-164-28U, 28-N4-36-199-32U, 28-N4-36-199-36U, 28-N4-38-199-34U, 28-N4-40-259-40U, 28-N4-42-159-38U, 28-N4-44-164-40U, 28-N4-32-259-32U, 28-N4-34-109-34U, 28-N4-36-109-36U, 28-N4-38-259-38U, 28-N4-46-114-46U, 28-N4-46-209-46U

Other

RA RA-82141

Model Numbers

28-N4-38-109-38U, 28-N4-40-114-40U, 28-N4-40-204-36U, 28-N4-40-204-40U, 28-N4-46-164-42U, 28-N4-46-259-42U, 28-N4-34-154-34U, 28-N4-40-154-36U, 28-N4-44-209-40U, 28-N4-44-259-40U, 28-N4-32-209-28U, 28-N4-34-154-30U, 28-N4-34-259-34U, 28-N4-36-154-36U, 28-N4-38-154-34U, 28-N4-38-154-38U, 28-N4-42-204-38U, 28-N4-46-164-46U, 28-N4-46-209-42U, 28-N4-32-164-32U, 28-N4-42-204-42U, 28-N4-44-114-44U, 28-N4-44-209-44U, 28-N4-44-259-44U, 28-N4-32-209-32U, 28-N4-34-209-30U, 28-N4-34-209-34U, 28-N4-36-154-32U, 28-N4-36-259-36U, 28-N4-38-199-38U, 28-N4-40-154-40U, 28-N4-42-114-42U, 28-N4-42-159-42U, 28-N4-42-259-42U, 28-N4-44-164-44U, 28-N4-32-104-32U, 28-N4-32-164-28U, 28-N4-36-199-32U, 28-N4-36-199-36U, 28-N4-38-199-34U, 28-N4-40-259-40U, 28-N4-42-159-38U, 28-N4-44-164-40U, 28-N4-32-259-32U, 28-N4-34-109-34U, 28-N4-36-109-36U, 28-N4-38-259-38U, 28-N4-46-114-46U, 28-N4-46-209-46U

Recall Numbers

82141

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-109-38U

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-114-40U

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-204-36U

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-204-40U

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-164-42U

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-259-42U

Product 7

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-154-34U

Product 8

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-154-36U

Product 9

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-209-40U

Product 10

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-259-40U

Product 11

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-209-28U

Product 12

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-154-30U

Product 13

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-259-34U

Product 14

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-154-36U

Product 15

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-154-34U

Product 16

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-154-38U

Product 17

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-204-38U

Product 18

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-164-46U

Product 19

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-209-42U

Product 20

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-164-32U

Product 21

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-204-42U

Product 22

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-114-44U

Product 23

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-209-44U

Product 24

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-259-44U

Product 25

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-209-32U

Product 26

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-209-30U

Product 27

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-209-34U

Product 28

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-154-32U

Product 29

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-259-36U

Product 30

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-199-38U

Product 31

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-154-40U

Product 32

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-114-42U

Product 33

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-159-42U

Product 34

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-259-42U

Product 35

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-164-44U

Product 36

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-104-32U

Product 37

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-164-28U

Product 38

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-199-32U

Product 39

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-199-36U

Product 40

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-199-34U

Product 41

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-40-259-40U

Product 42

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-42-159-38U

Product 43

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-44-164-40U

Product 44

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-32-259-32U

Product 45

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-34-109-34U

Product 46

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-36-109-36U

Product 47

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-38-259-38U

Product 48

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-114-46U

Product 49

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 28-N4-46-209-46U

Risk / hazard

Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Bolton Medical

Manufacturer

Not provided

Phone

Not provided

Brand: Bolton Medical.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

82141

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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