The Recall Desk
HighFDA (Devices)·Z-0391-2019·Announced 2018-11-14

Oscor TB Series Bipolar Pacing Leads Recalled for Connector Sliding

Oscor, Inc. is recalling TB Series Bipolar Pacing Leads because the connector cap housing may slide, potentially exposing the connection wire and causing loss of pacing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect can cause interruption of the pacing system, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Oscor, Inc. is recalling 36,688 units of TB Series Bipolar Pacing Leads, French Size 4F, 5F, and 6F. The affected leads are packaged for sterile single use in double trays and are distributed worldwide, including in the United States and numerous international countries.

The recall is due to a defect where the connector cap housing may slide during use. This sliding can potentially expose the connection wire, making it more susceptible to loss of connectivity or breakage during cable movement. Such failures can cause an interruption of the pacing system.

Healthcare facilities and consumers should identify affected units by checking the specific model numbers and lot numbers listed in the official recall notice. Users should stop using the affected leads and contact Oscor, Inc. for further instructions on replacement or return.

The recalled product

Product
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 tr
Manufacturer
Oscor, Inc.
Category
Medical Device — Cardiac Pacing Lead
Hazard
Affected units
36,688

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item Number (Lot Number): a. TB Lead
  • 4F Un-Shrouded
  • Model Number 020004 - 2B-81-532Z-D (OR-03868)
  • 2B-81-532Z-D (OR-03874)
  • 2B-81-532Z-D (C1-06951)
  • 2B-81-532Z-D (C1-06993)
  • 2B-81-532Z-D (C1-06994)
  • 2B-81-532Z-D (C1-07016)
  • 2B-81-532Z-D (C1-07018)
  • 2B-81-532Z-D (C1-07017)
  • 2B-81-532Z-D (D1-02633)
  • 2B-81-532Z-D (D1-02883)
  • 2B-81-532Z-D (DP-01395)
  • 2B-81-532Z-D (OR-04404)
  • 2B-81-532Z-D (C1-09074)
  • 2B-81-532Z-D (C1-09166)
  • 2B-81-532Z-D (DP-02801)
  • 2B-81-532Z-D (DP 02801)
  • 2B-81-532Z-D (DP-04451)
  • 2B-81-532Z-D (DP-05052)

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Related recalls

Same manufacturer · Oscor, Inc.

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Same hazard · loss of connectivity

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