Medtronic Vessel Cannulae Recalled for Potential Unsealed Sterile Packaging
Medtronic is recalling 5,719 vessel cannulae units due to potential for unsealed sterile packing, affecting worldwide distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving medical devices with potential for sterile packaging compromise, which presents risk of harm to patients, though no illnesses or injuries have been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 5,719 vessel cannulae (2 mm Model 30004 and 3 mm Model 30003) with worldwide distribution. The recall covers multiple specific lot numbers of these medical devices.
The cannulae are being recalled due to potential for unsealed sterile packing. This condition affects the integrity of the sterile packaging that protects the device prior to use.
Healthcare providers and patients should verify lot numbers against the FDA recall notice and contact Medtronic or their healthcare facility for additional guidance.
The recalled product
- Product
- Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Hazard
- Affected units
- 5,719
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 (12)
- a) Model Number 30004
- GTIN 00613994646156
- Lot Numbers: 2023041305
- GTIN 00673978179841
- Lot Numbers: 2023041300
- GTIN 20613994646150
- 2023041305
- 202306C194
- b) Model Number 30003
- GTIN 20613994646174
- Lot Numbers: 2023041298
- 202306C221
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Medtronic Perfusion Systems 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 13 products in this recall →Related recalls
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