FDAFDA · Food and drugs·Recall number Z-1797-2024
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, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,
Published May 22, 2024 · Recall initiated: March 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for unsealed sterile packing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- Worldwide distribution.
- Lot
- a) Model Number 12012, GTIN 20613994619246, Lot Numbers: 2023050080, 202306C144; b) Model Number 12008, GTIN 00643169880665, Lot Numbers: 2023040819; b) Model Number 12008, GTIN 00673978176307, Lot Numbers: 2023040819, 2023040820; b) Model Number 12008, GTIN 20643169880669, Lot Numbers: 2023040819, 2023040820, 202307C103; c) Model Number 12001, GTIN 00643169878686, Lot Numbers: 2023040810; c) Model Number 12001, GTIN 20643169878680, Lot Numbers: 2023040810, 2023040811, 202306C141; d) Model Number 12113, GTIN 20643169881338, Lot Numbers: 2023090675; e) Model Number 12016, GTIN 20613994540434, Lot Numbers: 2023050083, 202305C093; f) Model Number 12002, GTIN 20613994540465, Lot Numbers: 2023041178, 202305C079; g) Model Number 12220, GTIN 00613994540355, Lot Numbers: 2023041202, 2023050095; g) Model Number 12220, GTIN 20613994540359, Lot Numbers: 2023041202, 2023050095, 202305C096, 202306C159; h) Model Number 12010, GTIN 00673978176321, Lot Numbers: 2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075; h) Model Number 12010, GTIN 20613994619215, Lot Numbers: 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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