RELAY PRO Thoracic Stent-Graft System recall
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;
Why was RELAY PRO Thoracic Stent-Graft System recalled?
The stent-graft inside the delivery system was the incorrect size.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(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;
- Product
- 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;
- Recalling firm
- Bolton Medical Inc.
- Quantity
- 21 devices
- 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.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)