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

Recall Z-0391-2019 — TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an o

U.S. FDA — Device Enforcement · United States · 2018-09-26 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0391-2019
Date of alert: 2018-09-26
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Oscor, Inc.
Product category: device
Product type: Devices

Reported risk: During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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