PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Ma

FDA device recall Z-2740-2017 · posted 2017-06-19 · Terminated

Recall details

Recalling firm

Flowonix Medical, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LKK

Quantity affected

US: 2204 units

Distribution

Nationwide Distribution

Date initiated

2017-05-22

Date posted

2017-06-19

Date terminated

2018-06-28

Location

Mount Olive, NJ