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RelayPro Thoracic Stent-Graft System recallZ-1383-2024 · Bolton Medical Inc. · initiated Feb 22, 2024

Completed

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 stent-graft inside the delivery system was the incorrect size.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm issued letters dated and issued on 2/22/2024 via certified mail to it's U.S. customers. For OUS customers, the letters will be issued by 3/8/2024 due to the need to translate the letters into their local languages. The letter explained the reason for recall, risk to health, and actions to be taken by the customer/user. The instructions included completing the Acknowledgement Form, retaining a copy of it, and informing Terumo Aortic of any adverse events concerning the use of the affected product. The Acknowledgement Form indicates the consignee has read and understands the information contained in the letter, has taken the appropriate action, and disseminated the information to any affected staff, service, and/or facilities.

Recall details

Recall number
Z-1383-2024
Status
Completed
Initiated by the company
Feb 22, 2024
Posted by the FDA
Mar 27, 2024
Recalling firm
Bolton Medical Inc.
Quantity
21 devices
Product code
MIH
FDA submissions
P200045
Distribution
Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.

Product description

RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

(a) Part number 28-M4-34-100-34U - Lot #2112080111 and #2112080158, UDI 843576149656; (b) Part number 28-M4-30-095-30U - Lot #2112080147 and #2112080148, UDI 843576149632; (c) Part number 28-M4-46-155-46U - Lot #2112100328, UDI 843576149847; (d) Part number 28-M4-32-155-32S - Lot #B211209120, UDI 843576100183; (e) Part number 28-M4-36-250-32S - Lot #B211203197, UDI 843576100763; (f) Part number 28-M4-38-145-34S - Lot #B211206395, UDI 843576100572; (g) Part number 28-M4-38-190-38S - Lot #B211202319, UDI 843576100343; (h) Part number 28-M4-44-105-44S - Lot #B211209068, UDI 843576100114; (i) Part number 28-N4-22-099-22S - Lot #B211208120, UDI 843576100824; (j) Part number 28-N4-22-159-22S - Lot #B211208162, UDI 843576100954; (k) Part number 28-N4-24-099-24S - Lot #B211130071 and #B211207227, UDI 843576100831; (l) Part number 28-N4-28-204-24S - Lot #B211209065, UDI 843576101449; (m) Part number 28-N4-30-164-30U - Lot #2112100333, UDI 843576150584; (n) Part number 28-N4-32-164-28S - Lot #B211207181, UDI 843576101364; (o) Part number 28-N4-34-154-34U - Lot #2112090117, UDI 843576150607; (p) Part number 28-N4-34-209-30S - Lot #B211209073, UDI 843576101470; (q) Part number 28-CMP-3062-NC - Lot #2112100385, no UDI; and (r) Part number 28-CMP-3074-MC - Lot #2112100383, no UDI;

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

122 devices cleared under P200045 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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