Z-1572-2014Class II

MedStream Programmable Infusion Pump, 40 mL

Name: Z-1572-2014 MedStream Programmable Infusion Pump, 40 mL
Creator: Codman & Shurtleff, Inc.
Published: 2015-11-10
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2015-11-10 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the... on 2015-11-10. FDA classified it as Class II and gives the reason as "A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life". 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-1572-2014
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2014-05-09
Terminated: 2015-11-10
Recalling firm: Cerenovus, Inc.
Product: MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Root cause tag: design
FDA root cause: Device Design
Action: Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at [email protected] We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to
Quantity in commerce: 34
Distribution: Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
Product codes and lots: Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1572-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1571-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09
Z-1572-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)