[Recalled] Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. — Oscor, Inc | FDA 2012-07-25

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Oscor, Inc.

• OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II
• MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II
• MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II
• OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II
• MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II
• OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.