Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported March 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if n…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Perfusion Systems recalled Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, mod… - a critical-severity action.
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, mod… was recalled by Medtronic Perfusion Systems in March 19, 2025. Reason: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential har…. Check the official notice for the remedy. Verify recall #Z-1306-2025 with the FDA Devices before acting.
The recall
Medtronic Perfusion Systems issued this critical-severity FDA Devices recall-Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential har….
- Critical
- severity level
- 316K units
- affected scope
- Class I
- classification
- March 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1306-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1306-2025) was formally reported on March 19, 2025, with the manufacturer initiating the action on February 5, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Medtronic Perfusion Systems is listed as the recalling firm, operating out of Brooklyn Park, MN. Federal records list the affected scope as 316,205, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversi… Distribution data in the federal record shows the product reached: Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana …. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
316,205
Related Recalls
6
3 from same agency
Product description
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
Reason for recall
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1306-2025 |
| Date reported | March 19, 2025 |
| Date initiated | February 5, 2025 |
| Recalling firm | Medtronic Perfusion Systems |
| Firm location | Brooklyn Park, MN |
| Affected scope | 316,205 |
| Distribution | Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Cana… |
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-1306-2025) 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.
Frequently Asked Questions
What product was recalled? ▼
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014. Recalled by Medtronic Perfusion Systems. Units affected: 316,205.
Why was this product recalled? ▼
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2025. Severity: Critical. Recall number: Z-1306-2025.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Georgia Germany Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Moldova, Republic Of Montenegro Morocco Namibia Nepal Netherlands New Zealand North Macedonia NorthernIreland Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Suriname Sweden Switzerland Taiwan Thailand Turkey Ukraine United Arab Emirates United Kingdom Viet Nam Yemen.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1306-2025) 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 March 19, 2025. 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.