Product Wiki · Recalls · U.S. FDA — Device Enforcement

Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. Thi — recall Z-1000-2014

U.S. FDA — Device Enforcement · United States · 2014-01-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1000-2014
Date of alert: 2014-01-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc. Cardiac Rhythm Disease Management
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 12227513

Reported risk: Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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