TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve,…
Medical device recall Z-0391-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 30 states named
- 36,688 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
36,688 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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), 2B-81-532Z-D (DP-05115), 2B-81-532Z-D (DP-05225), 2B-81-532Z-D (DP-05371), 2B-81-532Z-D (DP-05482), 2B-81-532Z-D (DP-05516), 2B-81-532Z-D (DP-05938), 2B-81-532Z-D (DP05968), 2B-81-532Z-D (DP-05976), 2B-81-532Z-D (DP-05998), 2B-81-532Z-D (DP-06062), 2B-81-532Z-D (DP-06098), 2B-81-532Z-D (DP-06203), 2B-81-532Z-D (DP-07789), 2B-81-532Z-D (DP-07840), 2B-81-532Z-D (DP-08130); b. TB LEAD, 5F UN-SHROUDED, Model Number 020005 - 2B-81-532Z-E (D2-01795), 2B-81-532Z-E (C1-06923), 2B-81-532Z-E (C1-06946), 2B-81-532Z-E (C1-06947), 2B-81-532Z-E (C1-06945), 2B-81-532Z-E (C1-06997), 2B-81-532Z-E (C1-06995), 2B-81-532Z-E (C1-06996), 2B-81-532Z-E (C1-07013), 2B-81-532Z-E (C1-07015), 2B-81-532Z-E (C1-07012), 2B-81-532Z-E (C1-07014), 2B-81-532Z-E (D2-01939), 2B-81-532Z-E (D1-02542), 2B-81-532Z-E (D1-02805), 2B-81-532Z-E (DP-01259), 2B-81-532Z-E (DP-01455), 2B-81-532Z-E (DP-01554), 2B-81-532Z-E (OR-04380), 2B-81-532Z-E (C1-08496), 2B-81-532Z-E (C1-08486), 2B-81-532Z-E (C1-08497), 2B-81-532Z-E (C1-08495), 2B-81-532Z-E (OR-04407), 2B-81-532Z-E (C1-08487), 2B-81-532Z-E (C1-08488), 2B-81-532Z-E (C1-08499), 2B-81-532Z-E (C1-08494), 2B-81-532Z-E (C1-08498), 2B-81-532Z-E (C1-08678), 2B-81-532Z-E (C1-08676), 2B-81-532Z-E (C1-08677), 2B-81-532Z-E (C1-08686), 2B-81-532Z-E (C1-08687), 2B-81-532Z-E (C1-08688), 2B-81-532Z-E (C1-08689), 2B-81-532Z-E (C1-08691), 2B-81-532Z-E (C1-08685), 2B-81-532Z-E (C1-08679), 2B-81-532Z-E (C1-08693), 2B-81-532Z-E (C1-08694), 2B-81-532Z-E (DP-02161),…
FDA’s list runs to 15,238 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, MACEDONIA, MAURITIUS, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SENEGAL, SOUTH AFRICA, TAIWAN, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
The states and territories these words name
30 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Florida
- Hawaii
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Puerto Rico
- Rhode Island
- Tennessee
- Texas
- Utah
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 26, 2018.
- FDA classified it on Nov 8, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Aug 4, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oscor, Inc., of Palm Harbor, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 15,238 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.