TB Series Bipolar Pacing Leads — Class I medical device recall Z-0391-2019
Terminated recall by Oscor, Inc., reported 2018-11-14, distributed nationwide. During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the conne
| Recall number | Z-0391-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oscor, Inc., Palm Harbor, FL, United States |
| Recall initiated | 2018-09-26 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2022-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BG, BO, BR, CA, CO, CR, DE, DO, EC, EG, GB, GR, GT, IL, IN, IR, IT, JO, KW, LB, LV, MX, NZ, PA, PE, PH, PK, PL, RU, SA, SV, TR, TW, UA, VE, VN, ZA |
| Quantity | 36,688 units |
| Reason classes | device malfunction |
| Model numbers | 020004, 020005, 2B-81-532Z-D, 2B-81-532Z-E |
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 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.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0391-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.