Z-1691-2013Class I

MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine

Name: Z-1691-2013 MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine
Creator: Codman & Shurtleff, Inc.
Published: 2013-06-07
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-06-07 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump)... on 2013-06-07. FDA classified it as Class I and gives the reason as "Miscalibrated Fill Level Sensor may affect dosing level". 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-1691-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-07-16
Terminated: 2015-04-21
Recalling firm: Cerenovus, Inc.
Product: MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Miscalibrated Fill Level Sensor may affect dosing level
Root cause tag: design
FDA root cause: Device Design
Action: Codman issued a Medical Device Correction Notification to Medical Facilities dated June 7, 2013 via FedX to inform them of the potential problem and a Worksheet (instructions) to Identify Pumps with Miscalibrated FLS during each patient's next scheduled refill session or sooner if patient is symptomatic. If a pump is identified as having a miscalibrated FLS, notify Codman Neuro using the same worksheet. In addition a sample letter was provided to Physi cans to provide to patients on the system. Follow the recommendations for managing patients who are identified as having a pump with a miscalibrated FLS. For additional information,contact your Codman Neuro representative, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, Option 2.
Quantity in commerce: 5 US and and 360 OUS
Distribution: Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16
Z-1691-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)