FDA Devices recall · Reported July 24, 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.
Miscalibrated Fill Level Sensor may affect dosing level
Codman & Shurtleff, Inc. recalled MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofe… - a critical-severity action.
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofe… was recalled by Codman & Shurtleff, Inc. in July 24, 2013. Reason: Miscalibrated Fill Level Sensor may affect dosing level. Check the official notice for the remedy. Verify recall #Z-1690-2013 with the FDA Devices before acting.
The recall
Codman & Shurtleff, Inc. issued this critical-severity FDA Devices recall-Miscalibrated Fill Level Sensor may affect dosing level.
- Critical
- severity level
- 2 units
- affected scope
- Class I
- classification
- July 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1690-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
Miscalibrated Fill Level Sensor may affect dosing level
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1690-2013 |
| Date reported | July 24, 2013 |
| Date initiated | June 7, 2013 |
| Recalling firm | Codman & Shurtleff, Inc. |
| Firm location | Raynham, MA |
| Affected scope | 2 units US and 735 OUS |
| 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 Arabia, Portugal, Greece, Egypt, Switzerland… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1690-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026