Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93873

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 22, 2024
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Bolton Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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;

Z-1383-2024
Recall number
Z-1383-2024
Initiated
February 22, 2024
Classification
Class II
Status
Completed
Recalling firm
Bolton Medical Inc.
Quantity
21 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The stent-graft inside the delivery system was the incorrect size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

(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;

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.