Device recall: MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product…

Class I FDA enforcement event 65420. Recall start date: 7 Jun 2013. Status in the FDA record: Terminated. Termination date: 21 Apr 2015.

Reason for recall, in the words of FDA

Miscalibrated Fill Level Sensor may affect dosing level

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Codman & Shurtleff, Inc. started this device recall on 7 Jun 2013. The firm address in the FDA record is in Raynham, MA. FDA put the recall in Class I. FDA event 65420 has 2 product records. The first FDA enforcement report date is 24 Jul 2013. The record gives the status Terminated, with the termination date 21 Apr 2015.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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…

Recalling firm

Codman & Shurtleff, Inc., Raynham, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 65420: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1690-2013	MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.	2 units US and 735 OUS	Class I	Terminated	24 Jul 2013
Z-1691-2013	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.	5 US and and 360 OUS	Class I	Terminated	24 Jul 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class I: 6%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of Codman & Shurtleff, Inc.
Initiated	Product (first record)	Type	Class	Records
16 May 2019	GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).	Device	Class II	1
10 Nov 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the i	Device	Class II	2
5 Mar 2015	CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable	Device	Class II	1
15 Sep 2014	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for	Device	Class II	3
3 Jul 2014	Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device	Device	Class II	8
13 Dec 2013	CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 I	Device	Class II	1
11 Oct 2013	TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil an	Device	Class I	2
13 Aug 2013	MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrath	Device	Class I	8
16 May 2013	Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable	Device	Class II	7
11 Jan 2013	NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovascul	Device	Class II	24

Codman & Shurtleff, Inc.: all 11 events

Official channels

FDA enforcement report Z-1690-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 65420. https://recallregister.com/fda/i/65420/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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…
What quantity of product is in FDA event 65420?: The event has 2 product records. The first record gives this quantity: 2 units US and 735 OUS
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 6% of the 1,236 device events that started in 2013 are in Class I.