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Open, Classified

Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView 2.00 mm Intracoronary Shunt, Model Numbers: 31200

FDA Recall Z-1803-2024 · Posted 2024-05-10

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-03-19
Product Quantity1410 units

Reason for Recall

Potential for unsealed sterile packing.

Firm Action

Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120612MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTMedtronic, Inc. · 2012-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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