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Gyrus ACMI

Gyrus ACMI, LLC · Model 437A · UDI-DI 00821925005204

KOB Prescription

510(k) clearances

205

Adverse events (1 deaths)

Recalls

Facilities

Description

Straight Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 8 Inch (203 mm) Working Length

Recalls

Date	Firm	Reason
2019-04-22	Cook Inc.	Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
2019-04-22	Cook Inc.	Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
2005-07-22	Boston Scientific Corporation	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.