Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.
The agency’s classification
FDA (Devices): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Codman & Shurtleff, Inc. is recalling the MedStream Programmable Infusion Pump, an implantable device intended for the intrathecal delivery of Baclofen or Morphine. The recall is due to a miscalibrated fill level sensor that may affect the dosing level of the medication.
The recall involves 2 units in the United States and 735 units outside the United States. The affected products were distributed worldwide, including nationwide in the US and in countries such as Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey. All serial numbers are included in this recall.
Patients using these devices should contact their healthcare provider for instructions on how to proceed. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the device could cause serious adverse health consequences or death.
The recalled product
- Product
- 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.
- Manufacturer
- Codman & Shurtleff, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- HighCodman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
Same hazard · dosing error
See all →- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
- CriticalPediatric ALS organizers recalled over potentially harmful drug dosing errors
FDA (Food) · 2026-02-04
Similar recalls
- ModerateCodman MedStream Infusion Pump Recall for Low Battery Alarm Issue
FDA (Devices) · 2014-05-21
- SevereMedStream Programmable Pump Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- SevereCodman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- CriticalMedStream Refill Kit Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- SevereMedStream Refill Kit Recall for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- HighCodman Certas Programmable Valves Recalled for Potential Malfunction
FDA (Devices) · 2014-02-05