Bolton Medical Relay Pro Recall Lawsuit Investigation

Bolton Medical, Inc. is recalling its RelayPro Thoracic Stent-Graft System, N4 Non-Bare Stent Configuration, sizes 32mm and above. The FDA classified the action as a Class I recall, its most serious kind, on May 20, 2026. The graft’s proximal clasp can disconnect from the outer control tube. The device then cannot release from the delivery system, and no device-based bailout method has been identified. Bolton Medical has reported three deaths linked to this failure. Hospitals and clinicians should discontinue use of the RelayPro immediately, isolate remaining inventory and contact Terumo Aortic with questions. The FDA’s enforcement report lists the recall as open and classified under Recall Number Z-2160-2026.

Latest RelayPro Thoracic Stent-Graft System Recall Updates

July 17, 2026: FDA Updates Recall Recommendations

On July 17, 2026, the FDA updated its recall communication page for the RelayPro Thoracic Stent-Graft System to share updated recommendations from Bolton Medical [1]. The update follows the agency’s Class I classification of the action in May 2026 and marks the newest posted development on the device issue. As of the date this page was checked, no further FDA update had followed it.

June 15, 2026: Bolton Medical Issues Third Recall Notification

On June 15, 2026, Bolton Medical issued a third iteration of its Urgent Medical Device Recall notification by overnight mail. The notification carried a revised “Action to be taken” section. The notification followed an initial mailing in April and a second iteration in May, and it asked hospitals to confirm units on hand. It also required a signed acknowledgment form, even without affected product on hand.

May 29, 2026: Health Canada Publishes Its Own Recall Notice

On May 29, 2026, Health Canada published a Type I recall notice, Identification number RA-82141, for the same RelayPro device, covering its distribution in Canada [2]. Health Canada classified the action under its most serious recall category, matching the FDA’s Class I designation for the identical failure mode. It recorded May 25, 2026, as the action’s own classification date, four days before the public notice.

May 22, 2026: FDA Posts Enforcement Report and Recall Number

On May 22, 2026, the FDA posted its enforcement report for the action, assigning Recall Number Z-2160-2026 and Recall Event ID 98729 [3]. The report lists the recall status as open and classified, and names Bolton Medical, Inc. of Sunrise, Florida, as the recalling firm. It also classifies the device under product code MIH, the FDA’s category for endovascular aortic-aneurysm grafts.

May 20, 2026: FDA Classifies Action as a Class I Recall

On May 20, 2026, the FDA updated its recall communication page. It stated that it had classified the RelayPro action as a Class I recall. The agency called it its most serious category for a device that may cause serious injury or death. The classification came two weeks after Bolton Medical had already moved to a full-removal strategy on May 5.

May 5, 2026: Bolton Medical Updates Recall Strategy to Removal

On May 5, 2026, Bolton Medical issued a second iteration of its recall notification. The update changed the recall strategy from a correction to a full removal. Hospitals were asked to isolate affected inventory rather than continue using the recalled reference numbers while awaiting the firm’s further instructions. The change came about a week after the FDA’s April 28 Early Alert first flagged the issue publicly.

April 28, 2026: FDA Issues an Early Alert on the Device

On April 28, 2026, the FDA issued an Early Alert about a potentially high-risk issue with the RelayPro system [4]. The alert came ahead of any formal recall classification. The alert told clinicians to weigh alternative stent-graft options and review existing bailout techniques before using any affected device. The FDA said it would keep the public informed and update its communication page as significant new information became available.

April 23, 2026: Bolton Medical Reports Three Deaths

On April 23, 2026, Bolton Medical sent affected customers a letter recommending changes to the instructions for use and reported three deaths tied to the graft-release failure. The letter attributed one death to aortic perforation and two more to stroke following conversion to open surgery during the procedure.

April 22, 2026: Bolton Medical Initiates the Recall

On April 22, 2026, Bolton Medical initiated the recall action that the FDA would later classify as Class I, per the FDA’s enforcement report. The firm’s initial notification asked consignees to review their inventory of affected devices on hand at each facility. It covered every N4 Non-Bare Stent Configuration unit sized 32mm and above, the scope every later recall notice kept.

Which Bolton Medical Relay Pro Devices Are Affected?

The recall covers every device in the N4 Non-Bare Stent Configuration line: eight proximal diameters, 49 reference/DI numbers from the FDA’s enforcement report, each with its own DI code:

• 32mm devices: six reference numbers, starting with 28-N4-32-104-32U.
• 34mm devices: six references, beginning at 28-N4-34-109-34U.
• 36mm devices: a run of six references opening with 28-N4-36-109-36U.
• 38mm devices: six references, the lowest reading 28-N4-38-109-38U.
• 40mm devices: six references in this group, led by 28-N4-40-114-40U.
• 42mm devices: six references, the set opening at 28-N4-42-114-42U.
• 44mm devices: seven reference numbers, starting with 28-N4-44-114-44U.
• 46mm devices: the last size group, six references beginning with 28-N4-46-114-46U.

Clinicians should confirm each device’s reference number against Bolton Medical’s recall list or the FDA’s report before returning or continuing to use any device.

Why Was Bolton Medical Relay Pro Recalled?

Bolton Medical recalled the RelayPro Thoracic Stent-Graft System because the graft’s proximal clasp disconnects from the outer control tube. When that happens, the device cannot be released from the delivery system. The company said the failure can occur without warning. The FDA’s enforcement report lists the cause as still under investigation. No device-based bailout method exists once the failure occurs. The team may then need to convert to open surgical repair, which the FDA says can result in patient death. Difficulty releasing the stent graft can also delay the procedure or shift the graft’s position before the team completes it.

Reported Incidents, Injuries, or Illnesses

Bolton Medical has reported three deaths connected to the RelayPro’s release failure, based on complaints received through April 23, 2026. One death followed an aortic perforation, and two followed conversion to open surgery that led to stroke. Health Canada’s notice also discloses Bolton Medical’s complaint count: four complaints of this failure mode worldwide. Three of these resulted in the same three deaths, and the fourth complaint did not involve a death. Reports of an incident do not by themselves prove the device caused every injury. The FDA and Bolton Medical continue reviewing each case and have asked hospitals to report further events.

What Should Consumers Do?

Hospitals, clinicians and patients connected to the RelayPro Thoracic Stent-Graft System recall should take the following steps:

1. Discontinue use of the RelayPro system immediately.
2. Review inventory and isolate affected reference numbers to prevent further use.
3. If a device was transferred to another facility, forward the recall notification there.
4. Complete Bolton Medical’s acknowledgment form, even if no affected product remains on hand.
5. Return affected devices to Terumo Aortic using the prepaid UPS label, or call Sedgwick, Inc. at 888-719-5830 for return assistance.
6. Report any adverse reactions or quality problems to Terumo Aortic at Market_Actions-TMC@terumomedical.com or to the FDA’s MedWatch program [5].

Other Recalls, Warnings, or International Actions

Health Canada published its own recall notice for the RelayPro on May 29, 2026 (Identification number RA-82141), its most serious Type I category. It covers the same clasp-disconnection failure the FDA identified, and no other country’s regulator has published a separate notice for this device.

Legal Options

No lawsuit, class action or MDL over the RelayPro has been found in Schmidt & Clark’s search as of the date this page was checked. Given the Class I classification and the reported deaths noted above, some families may want a legal review of the device’s use. A recall does not automatically establish that a company is liable, or that the device defect caused a specific injury or death.

Frequently Asked Questions

Who Can Hospitals Contact for More Information About the RelayPro Recall?

Hospitals can contact Bolton Medical for more information about the RelayPro recall by calling Kimberly Feitl at 954-838-9699. For adverse-event or product questions, they can also email Terumo Aortic at Market_Actions-TMC@terumomedical.com.

What Is the Mailing Address for Returning a RelayPro Device?

The mailing address for returning a RelayPro device is Sedgwick, Inc., Attn: Event 6732, 2670 Executive Dr., Suite A, Indianapolis, Indiana. Use the prepaid UPS label, or call 888-719-5830 for help.

What Causes the RelayPro Stent Graft to Fail?

The RelayPro stent graft fails when its clasp cannot release from the delivery system. Users may notice resistance loss when sliding the apex holder back, then a failure to release the stent, leaving an implant that cannot be recaptured.

What Is the RelayPro Device Used to Treat?

The RelayPro device is used to treat damaged or weakened sections of the thoracic aorta, including aneurysms, dissections, or tears. It works by placing a stent graft that reinforces the vessel and maintains blood flow.

Where Was the Bolton Medical RelayPro Device Distributed?

The Bolton Medical RelayPro device was distributed to hospitals worldwide, per the FDA’s report. Locations included the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico and the United Kingdom.

Did Health Canada Also Recall the RelayPro Device?

Yes, Health Canada also recalled the device. Its notice categorizes the action under “Health products – Medical devices – Cardiovascular” with a Healthcare-professional audience. It confirms the same clasp-disconnection issue the FDA found in the United States.

Can a Family File a Legal Claim After a Death Linked to the Bolton Medical RelayPro Recall?

A family may be able to file a legal claim after a death linked to the Bolton Medical RelayPro recall. The FDA’s Class I classification and the three reported deaths are the key facts. Deadlines are set by state law and depend on when the death occurred.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/thoracic-stent-graft-recall-bolton-medical-removes-relay-pro-system
2. https://recalls-rappels.canada.ca/en/alert-recall/relayrpro-thoracic-stent-graft-system
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219579
4. https://fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-thoracic-stent-graft-issue-bolton-medical
5. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program