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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
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 being conducted because a miscalibrated fill level sensor may affect the dosing level of the medication delivered by the pump.
The affected units include product codes 91-4201US and 91-4201 (40ml pump). The recall covers 5 units in the United States and 360 units outside the United States. Distribution was worldwide, including nationwide distribution in the US and specific countries such as Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
Patients using these devices should contact their healthcare provider for instructions on how to proceed. The source text does not specify the exact corrective action or replacement timeline, but the recall is classified as Class I by the FDA.
The recalled product
- 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.
- 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
- 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
- SevereCodman Lumbar Drainage Catheter Kit 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