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DLP recallZ-1797-2024 · Medtronic Perfusion Systems · initiated Mar 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for unsealed sterile packing.

FDA root cause category: Process control

What the company is doing

Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

Recall details

Recall number
Z-1797-2024
Status
Open, Classified
Initiated by the company
Mar 19, 2024
Posted by the FDA
May 10, 2024
Recalling firm
Medtronic Perfusion Systems
Quantity
13954 units
Product code
DWF
FDA submissions
K850385
Distribution
Worldwide distribution.

Product description

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,

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K850385 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94274).

Sources and updates

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