FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: 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.
- Recall number
- Z-1572-2014
- Recalling firm
- Codman & Shurtleff, 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.
- Status
- Terminated
- Initiated
- 2015-11-10
- Posted
- 2014-05-09
- Terminated
- 2015-11-10
- Reason
- A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
- 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 Codmanproductcomplaints@dpyus.jnj.com 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
- 34
- Distribution
- Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P890055"]
- Product code
- LKK
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28