Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 28, 2013
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labe
Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic MiniMed recalled Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) … - a moderate-severity action.
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) … was recalled by Medtronic MiniMed in August 28, 2013. Reason: Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3…. Check the official notice for the remedy. Verify recall #Z-1986-2013 with the FDA Devices before acting.
The recall
Medtronic MiniMed issued this moderate-severity FDA Devices recall-Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3….
- Moderate
- severity level
- 670K units
- affected scope
- Class II
- classification
- August 28, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1986-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1986-2013) was formally reported on August 28, 2013, with the manufacturer initiating the action on July 3, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic MiniMed is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 669,672 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay an…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
669,672 units
Related Recalls
6
3 from same agency
Product description
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units
Reason for recall
Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1986-2013 |
| Date reported | August 28, 2013 |
| Date initiated | July 3, 2013 |
| Recalling firm | Medtronic MiniMed |
| Firm location | Northridge, CA |
| Affected scope | 669,672 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela. |
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-1986-2013) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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.
Frequently Asked Questions
What product was recalled? ▼
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units. Recalled by Medtronic MiniMed. Units affected: 669,672 units.
Why was this product recalled? ▼
Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-1986-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1986-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 28, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.