Lower risk Medical device recall · FDA · Published September 26, 2018

Oscor TB Series Bipolar Pacing Leads Recall: Connector Cap May Slide

Oscor recalls TB Series Bipolar Pacing Leads with 2mm unshrouded connectors for potential connector cap sliding, risking wire breakage during movement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0391-2019Medical device Oscor ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmOscor, Inc.3816 Desoto Blvd · Palm Harbor, FL 34683-1618

✎ GovInfoNow plain-language explainer

Oscor is recalling TB Series Bipolar Pacing Leads with 2mm unshrouded connectors because the connector cap housing may slide, potentially exposing the connection wire. This could cause the wire to break or lose connectivity during movement, disrupting the pacing system. Read more at govinfonow.com/recall/69768-oscor-tb-series-bipolar-pacing-leads-recall-connector-cap-may.

Source Summary by GovInfoNow · govinfonow.com/recall/69768-oscor-tb-series-bipolar-pacing-leads-recall-connector-cap-may · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0391-2019

Cite this page

“Oscor TB Series Bipolar Pacing Leads Recall: Connector Cap May Slide.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69768-oscor-tb-series-bipolar-pacing-leads-recall-connector-cap-may. Based on FDA recall #Z-0391-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0391-2019%22&limit=1).

The FDA announced on 2018-09-26 that Oscor Inc. is recalling TB Series Bipolar Pacing Leads due to a hazard where connector caps may slide and expose wires, potentially causing breakage. The agency issued recall number Z-0391-2019 for the Class I device.

How to tell if you have it

Brand: Oscor
Product: TB Series Bipolar Pacing Leads
Sizes: French Size 4F, 5F, 6F
Curve Types: Straight, Atrial J, 60 degree Curve, Right Heart
Connectors: 2mm unshrouded
Model Numbers: 020004, 020005, 020006, 020010, 020011, 020012, 020016, 020017, 020018, 020022, 020023, 020024
Lot Codes: See detailed list in FACTS (e.g., 2B-81-532Z-D, 2B-81-532Z-E, etc.)
Units Affected: 36,688

The hazard

During use of some TB Temporary Bipolar Pacing Leads with 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. This exposure can make the wire susceptible to loss of connectivity or breakage during cable movement, causing interruption of the pacing system.

Context

GovInfoNow's records show Oscor Inc. has issued 3 other recalls since 2021-03-10. On 2026-06-10, Oscor Abiomed recalled an Introducer Kit due to potential sheath leakage risk. Other recent recalls of similar products include Olymp BiCOAG Hemostasis Probe Connector Recall (2026-08-19) and Medline NAMIC Angiographic Control Syringes Recall (2026-02-27).

How to tell if you have this one

Check for TB Series Bipolar Pacing Leads with French Sizes 4F, 5F, or 6F, and specific curve types including Straight, Atrial J, or 60-degree Curve. The product is labeled with model numbers like 020004, 020005, or 020006.

Brand
Oscor
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number on the lead, such as 020004 for 4F size, to confirm if it's in the recalled list.
Contact Manufacturer
If you have the recalled leads, contact Oscor directly for instructions on how to return or replace them.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 28 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 3.9 years after the firm started it.

Sep 26, 2018Firm started the recall
Nov 8, 2018FDA classified it Class I
Nov 14, 2018Published in FDA’s Enforcement Report
Aug 4, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these leads safe to use?

The recall indicates a potential risk of connector cap sliding, but the leads are not unsafe for normal use. The manufacturer recommends checking if they are in the recalled list.

Similar recalls

Latest medical device recalls

Keep exploring

More Oscor recalls

Link to this recall

<a href="https://govinfonow.com/recall/69768-oscor-tb-series-bipolar-pacing-leads-recall-connector-cap-may">Oscor TB Series Bipolar Pacing Leads Recall: Connector Cap May Slide (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0391-2019 (September 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0391-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.