Medtronic Arterial Cannulae Recalled Due to Unsealed Sterile Packaging
Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.
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: This is a Class II FDA recall for a medical device with compromised sterile barrier integrity. No illnesses or injuries are reported in the source, but unsealed sterile packaging on surgical devices presents a risk of contamination and infection. The score reflects risk-of-harm for products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling multiple models of arterial cannulae distributed worldwide. The recall affects 13,033 units across various model numbers and sizes, including DLP Curved Metal Tip, DLP One-Piece Pediatric, EOPA Elongated One-Piece, and Select Series variants.
The recalled devices have a potential for unsealed sterile packaging. Unsealed sterile packing compromises the sterile barrier of the medical device, which is critical for maintaining device sterility prior to use in clinical and surgical applications.
The recalled product
- Product
- Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved…
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Surgical Device
- Affected units
- 13,033
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 (20)
- a) Model Number 80020
- GTIN 20643169485703
- Lot Numbers: 2023040597
- 2023041061
- 202305C247
- b) Model Number 80220
- GTIN 20643169485734
- Lot Numbers: 2023031390
- 2023040098
- 202305C249
- 202310C155
- c) Model Number 82020
- GTIN 20643169485536
- Lot Numbers: 2023041063
- 2023041396
- 202305C253
- d) Model Number 87120
- GTIN 00673978187105
- Lot Numbers: 2023040600
- GTIN 20613994879114
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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