POWERPORT CLEARVUE isp — Class II medical device recall Z-2080-2019
Completed recall by Bard Peripheral Vascular Inc, reported 2019-07-31, distributed nationwide. Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack o
| Recall number | Z-2080-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2018-06-25 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 95 units |
Product
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Reason for recall
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
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-2080-2019. 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.