FDA-Device2022-04-20Class II
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Hazard
Pouch seals may be open, compromising sterility.
Sold states
Distribution in the US and territories, Japan, and Canada
Affected count
488 5-packs
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2022More Boston Scientific Corporation recalls
- FDA-Device2026-07-08CRE Pro Wireguided 12-15mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 10-12mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 15-18mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 6-8mm 240cm
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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