Medtronic Left Heart Vent Catheters recalled for unsealed sterile packaging
Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.
What this means for you
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 medical device recall for potential unsealed sterile packing. No illnesses or injuries reported. This represents a risk-of-harm situation where contamination of sterile medical devices could affect patient safety.
Plain-English summary
Medtronic Perfusion Systems is recalling multiple models of Left Heart Vent Catheters due to potential for unsealed sterile packing. The recall affects approximately 13,954 units distributed worldwide. Affected models include the DLP Intracardiac Sump and DLP Left Heart Vent Catheters in sizes 10 Fr, 13 Fr, 16 Fr, and 20 Fr, as well as the DLP Pericardial Sump.
These devices are supplied sterile for use in medical procedures. If sterile packing is unsealed, the devices may become contaminated, compromising their sterility.
Healthcare facilities and medical professionals should check their inventory against the specific model numbers and lot numbers provided in the official FDA recall notice. Any affected units should be quarantined immediately and not used. Refer to the complete FDA recall notice for the full list of affected lot numbers.
The recalled product
- Product
- Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 13,954
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 12012
- GTIN 20613994619246
- Lot Numbers: 2023050080
- 202306C144
- b) Model Number 12008
- GTIN 00643169880665
- Lot Numbers: 2023040819
- GTIN 00673978176307
- 2023040820
- GTIN 20643169880669
- 202307C103
- c) Model Number 12001
- GTIN 00643169878686
- Lot Numbers: 2023040810
- GTIN 20643169878680
- 2023040811
- 202306C141
- d) Model Number 12113
- GTIN 20643169881338
- Lot Numbers: 2023090675
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.
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