| Date Initiated by Firm | April 22, 2026 |
|---|
| Date Posted | May 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2160-2026 |
|---|
| Recall Event ID |
98729 |
| PMA Number | P200045 |
|---|
| Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
|
| Product | RelayPro Thoracic Stent-Graft System (various sizes)
Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U |
|---|
| Code Information |
All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461;
28-N4-32-164-28U/ 32/ (01)00843576150959;
28-N4-32-164-32U/ 32/ (01)00843576150591;
28-N4-32-209-28U/ 32/ (01)00843576151055;
28-N4-32-209-32U/ 32/ (01)00843576150720;
28-N4-32-259-32U/ 32/ (01)00843576150850;
28-N4-34-109-34U/ 34/ (01)00843576150478;
28-N4-34-154-30U/ 34/ (01)00843576150966;
28-N4-34-154-34U/ 34/ (01)00843576150607;
28-N4-34-209-30U/ 34/ (01)00843576151062;
28-N4-34-209-34U/ 34/ (01)00843576150737;
28-N4-34-259-34U/ 34/ (01)00843576150867;
28-N4-36-109-36U/ 36/ (01)00843576150485;
28-N4-36-154-32U/ 36/ (01)00843576150973;
28-N4-36-154-36U/ 36/ (01)00843576150614;
28-N4-36-199-32U/ 36/ (01)00843576151079;
28-N4-36-199-36U/ 36/ (01)00843576150744;
28-N4-36-259-36U/ 36/ (01)00843576150874;
28-N4-38-109-38U/ 38/ (01)00843576150492;
28-N4-38-154-34U/ 38/ (01)00843576150980;
28-N4-38-154-38U/ 38/ (01)00843576150621;
28-N4-38-199-34U/ 38/ (01)00843576151086;
28-N4-38-199-38U/ 38/ (01)00843576150751;
28-N4-38-259-38U/ 38/ (01)00843576150881;
28-N4-40-114-40U/ 40/ (01)00843576150508;
28-N4-40-154-36U/ 40/ (01)00843576150997;
28-N4-40-154-40U/ 40/ (01)00843576150638;
28-N4-40-204-36U/ 40/ (01)00843576151093;
28-N4-40-204-40U/ 40/ (01)00843576150768;
28-N4-40-259-40U/ 40/ (01)00843576150898;
28-N4-42-114-42U/ 42/ (01)00843576150515;
28-N4-42-159-38U/ 42/ (01)00843576151000;
28-N4-42-159-42U/ 42/ (01)00843576150645;
28-N4-42-204-38U/ 42/ (01)00843576151109;
28-N4-42-204-42U/ 42/ (01)00843576150775;
28-N4-42-259-42U/ 42/ (01)00843576150904;
28-N4-44-114-44U/ 44/ (01)00843576150522;
28-N4-44-164-40U/ 44/ (01)00843576151017;
28-N4-44-164-44U/ 44/ (01)00843576150652;
28-N4-44-209-40U/ 44/ (01)00843576151116;
28-N4-44-209-44U/ 44/ (01)00843576150782;
28-N4-44-259-40U/ 44/ (01)00843576151215;
28-N4-44-259-44U/ 44/ (01)00843576150911;
28-N4-46-114-46U/ 46/ (01)00843576150539;
28-N4-46-164-42U/ 46/ (01)00843576151024;
28-N4-46-164-46U/ 46/ (01)00843576150669;
28-N4-46-209-42U/ 46/ (01)00843576151123;
28-N4-46-209-46U/ 46/ (01)00843576150799;
28-N4-46-259-42U/ 46/ (01)00843576151222
|
| FEI Number |
1000135961
|
Recalling Firm/
Manufacturer |
Bolton Medical Inc.
799 International Pkwy
Sunrise
FL
33325-6220
|
| For Additional Information Contact | Kimberly Feitl
954-838-9699 |
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Manufacturer Reason
for Recall | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On June 15, 2026, Bolton Medical Inc. (subsidiary of Terumo Aortic) issued a 3rd iteration of the Urgent Medical Device Recall (Removal) notification via overnight mail. The updated communication contained a revised "Action to be taken" section as well as acknowledgment form. Initial notification was sent on April 22, 2026. and a 2nd iteration was issued on May 5, 2026, a 2nd iteration was issued updating the recall strategy to removal. Bolton Medical ask consignees to take the following actions:
1. Discontinue use of the Relay Pro immediately.
2. Review your Relay Pro Inventory and immediately isolate affected inventory to prevent future use.
3. If devices have been transferred to another facility, please provide them with a copy of this notification and instruct them to follow the actions in this section.
4. Complete the acknowledgment form indicating the number of units in your control to be returned to Terumo. The form is required even if you do not have product on hand.
6. Return affected product to the address below using the enclosed prepaid UPS return label and include a copy of Appendix 1 as the packing slip with your physical product return. For shipping assistance or additional labels, please call Sedgwick at 888-719-5830.
Sedgwick, Inc.; Attn: Event 6732, 2670 Executive Dr., Suite A, Indianapolis, IN 46241.
|
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| Distribution | Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = MIH
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