Z-2740-2017Class II

PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number...

Name: Z-2740-2017 PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number...
Creator: Flowonix Medical, Inc.
Published: 2017-05-22
License: https://open.fda.gov/license/

Flowonix Medical Inc / initiated 2017-05-22 / Terminated / root cause: design

FDA source

Flowonix Medical, Inc. began a recall of PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc... on 2017-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2740-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-06-19
Terminated: 2018-06-28
Recalling firm: Flowonix Medical Inc
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).
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: design
FDA root cause: Under Investigation by firm
Action: Flowonix sent an URGENT MEDICAL DEVICE CORRECTION Letter and Response Forms dated May 22, 2017, with updated instructions were sent via UPS 2nd Day Air on May 25, 2017 to healthcare professionals: physicians and MRI facilities and technicians. The documents will also be available at www.flowonix.com. A Correction Letter will also be sent to patients to inform them of the labeling changes. For further questions, please call (973) 426-9229.
Quantity in commerce: US: 2204 units
Distribution: Nationwide Distribution
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2740-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2740-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-17

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)