The Recall Desk
SevereFDA (Devices)·Z-1306-2025·Announced 2025-03-19

Aortic Root Cannula Recall for Loose Male Luer Component

Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity of 4. The potential hazard—stroke during cardiac surgery—constitutes a risk of serious injury, meeting the criterion for Severe classification.

Plain-English summary

Medtronic Perfusion Systems is recalling 316,205 aortic root cannulas due to the presence of unexpected loose material in the male luer connector. The affected models include DLP Aortic Root Cannulas (11012 and 11014), MiAR Cannulas (11012L and 11014L), and DLP Aortic Root Cannulas with Vent Line (21012 and 21014). These devices were distributed nationwide in the United States and to numerous countries internationally.

The loose material in the male luer connection point poses a risk during cardiac surgery. If detected before use, it will delay the surgical procedure while the device is replaced. If not detected before the device is used, it could cause stroke—either reversible or irreversible—potentially resulting in serious patient harm.

Healthcare facilities using these cannulas should immediately halt use and check their inventory against the lot numbers and UDI-DI codes specified in the official FDA recall notice. Affected units were manufactured between 2022 and 2024.

Contact Medtronic Perfusion Systems immediately to report any adverse events or to arrange replacement devices. Physicians and surgical teams should review this notice and ensure no affected units are used in patient care.

The recalled product

Product
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, m
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Surgery / Perfusion Equipment
Hazard
  • loose-material
  • stroke

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 (6)

  • 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA
  • model no 11012 i. UDI-DI 00613994495457
  • model no. 11014 i. UDI-DI 00613994495488
  • model no 11012L i. UDI-DI 00613994495464
  • model no. 21012 i. UDI-DI 00613994495396
  • model no. 21014 i. UDI-DI 00613994495402

Distribution

Distributed nationwide across the United States.

Related recalls

Same category