The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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…
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:

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