RELAY PRO Thoracic Stent-Graft System recalled for incorrect size
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect—the stent-graft is the wrong size. No illnesses or injuries have been reported in the source material. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' meeting the threshold for High (3) severity.
Plain-English summary
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems due to a manufacturing defect. The stent-graft contained within the delivery system is the incorrect size.
The recalled devices were distributed worldwide. In the United States, distribution occurred in Arizona, Massachusetts, and Texas. Internationally, the devices were distributed to Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.
Healthcare providers and patients should verify whether any of these recalled devices were received or implanted. The specific part numbers and lot numbers affected by this recall have been identified in the FDA recall notice for device identification purposes.
The recalled product
- 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
- Manufacturer
- Bolton Medical Inc.
- Hazard
- wrong-size
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (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
Distribution
Distributed nationwide across the United States.
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