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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87952

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

Open FDA event record

Event summary

Timeline bucket
May 04, 2021
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medtronic Vascular

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

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.

Z-1860-2021
Recall number
Z-1860-2021
Initiated
May 04, 2021
Classification
Class I
Status
Terminated
Recalling firm
Medtronic Vascular
Quantity
54,997 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

Code information

GTIN: 00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20613994994534. Serial Number/Lot Number GFRF0544 GFTJ1064 GFTJ2054 GFWD3486 GFAP4022 GFAP4023 GFAR1705 GFAS0270 GFAS0271 GFAU2099 GFAU2100 GFAV2023 GFAW0536 GFAX0346 GFAX0347 GFAX0348 GFAX0349 GFAY0671 GFAY0672 GFAZ0120 GFAZ0121 GFBN0459 GFBP1047 GFBP1048 GFBQ1629 GFBQ1630 GFBQ1631 GFBW0577 GFCV1818 GFCX1086 GFDP0187 GFWE3973 GFWE3974 GFWF3611 GFWG4429 GFWG4430 GFWG4432 GFWH2553 GFWI3563 GFWK0060 GFWK0061 GFWK0062 GFWL0066 GFWL2778 GFWL2780 GFXB0138 GFXB0141 GFXB3088 GFXB3089 GFXB3090 GFXC3702 GFXC3703 GFXD4073 GFXD4074 GFXF2023 GFXF2024 GFXF2025 GFXG1318 GFXG1320 GFXH2124 GFXH2125 GFXI1282 GFXI1445 GFXJ0688 GFXJ0689 GFYE0603 GFYF0667 GFYG1165 GFZA1155 GFZA1156 GFZB0256 GFZB0257 GFZC1428 GFZF0937 GFZH0811 GFZH0812 GFZJ1128 GFUG2639 GFTH1503 GFTJ0708 GFBY3756 GFXJ0691 GFRI1386 GFXC3695 GFXI1280 GFYA2177 GFYK1425 GFYK1426 GFYL2107 GFZA1161 GFZA1162 GFZB1164 GFZB1165 GFZB1166 GFZC0833 GFZC0834 GFZC0835 GFAN0034 GFAN3402 GFAQ4326 GFAS1779 GFAT2205 GFAU2102 GFAV2025 GFAW0540 GFAX0351 GFAY2480 GFAZ1728 GFBN0463 GFBP1051 GFBP2548 GFBQ2337 GFBS2989 GFBT1262 GFBU1912 GFBU1913 GFBV2111 GFBW0580 GFBX2576 GFBX2578 GFBY0801 GFCT1918 GFCU1707 GFCV3653 GFCW0885 GFCX3692 GFCY3186 GFCZ1176 GFDP1294 GFDQ1045 GFDR0722 GFDT3017 GFDT3533 GFDV0352 GFDV3567 GFDV3568 GFDW2107 GFDW2108 GFDX2649 GFDY2057 GFER1570 GFEV0322 GFEV0323 GFEV0325 GFYG1612 GFYI0525 GFYI0722 GFYJ0508 GFYJ2628 GFYK1607 GFYL2108 GFZA1163 GFZC1455 GFZF0944 GFZG0922 GFZH1464 GFZJ1140 GFZK1538 GFZL0749

Distribution pattern

US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia