NC Tenku RX PTCA Balloon Catheter — Class I medical device recall Z-2039-2017
Terminated recall by Abbott Vascular, reported 2017-05-24. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can r
| Recall number | Z-2039-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-05-12 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-02-07 |
| Lot numbers | 50202G1, 50204G1, 50406G1, 50901G1, 60202G1, 60301G1, 60302G1, 60401G1, 60502G1, 60506G1, 60601G1, 60701G1, 60801G1, 60805G1, 60902G1, 61004G1, 61101G1 |
| Model numbers | 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T |
Product
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
Reason for recall
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
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-2039-2017. 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.