PROMETRA II Programmable Infusion Pump — Class II medical device recall Z-2740-2017
Terminated recall by Flowonix Medical, Inc., reported 2017-07-26, distributed nationwide. Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have
| Recall number | Z-2740-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flowonix Medical, Inc., Mount Olive, NJ, United States |
| Recall initiated | 2017-05-22 |
| Classified | 2017-07-17 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2018-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,204 units |
| Model numbers | 11823, 11825, 13827, 830, PL-21794-00, PL-21798-02, PL-22790-02, PL-31790-02 |
Product
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
Reason for recall
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
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-2740-2017. 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.