Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging
Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is unsealed sterile packing on surgical devices, which represents a potential risk of contamination. Per the rubric, theoretical hazards without reported harm are classified as High for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae across multiple models and sizes. The recalled products include DLP single-stage, MC2 two-stage, and VC2 two-stage cannulae used in cardiovascular and extracorporeal perfusion procedures.
The recall was initiated due to potential for unsealed sterile packing on affected units. Unsealed sterile packaging could compromise the sterility of the medical devices.
The affected devices were distributed worldwide to hospitals and healthcare facilities. Patients and healthcare providers who have devices from this recall should contact Medtronic Perfusion Systems or consult with their healthcare provider.
The recalled product
- Product
- Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr.…
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 17,221
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 68120
- GTIN 20613994879435
- Lot Numbers: 2023041436
- b) Model Number 68124
- GTIN 00613994879417
- Lot Numbers: 2023041441
- 2023041448
- GTIN 00681490466349
- GTIN 20613994879411
- 202306C008
- c) Model Number 68128
- GTIN 00613994879394
- Lot Numbers: 2023041040
- GTIN 00681490466363
- Lot Numbers: 2023041388
- GTIN 20613994879398
- 2023041388
- 202306C010
- 202306C011
- d) Model Number 68130
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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