Skip to content

Medtronic Arterial Cannulae packaged as recallZ-1793-2024 · 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-1793-2024
Status
Open, Classified
Initiated by the company
Mar 19, 2024
Posted by the FDA
May 10, 2024
Recalling firm
Medtronic Perfusion Systems
Quantity
13033 units
Product code
DWF
FDA submissions
K840002
Distribution
Worldwide distribution.

Product description

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 Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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, Lot Numbers: 2023040600, 2023041066, 202306C018; e) Model Number 80222, GTIN 20643169485741, Lot Numbers: 2023041062, 202308C058; f) Model Number 87122, GTIN 00613994879103, Lot Numbers: 2023040601; GTIN 20613994879107, Lot Numbers: 2023040601, 2023041067, 202306C017; g) Model Number 87220, GTIN 00643169485563, Lot Numbers: 2023031282, 2023040602, 2023041068; GTIN 20643169485567, Lot Numbers: 2023031282, 2023031283, 2023031391, 2023040602, 2023041068, 202306C006, 202306C247; h) Model Number 87222, GTIN 00643169485570, Lot Numbers: 2023041408; GTIN 20643169485574, Lot Numbers: 2023041069, 2023041408, 202306C007; i) Model Number 77006, GTIN 20763000091013, Lot Numbers: 2023040943, 202306C056; j) Model Number 77206, GTIN 20763000091020, Lot Numbers: 2023041347, 202308C108; k) Model Number 77008, GTIN 20763000091105, Lot Numbers: 2023040944, 2023040946, 02306C020, 202308C084; l) Model Number 77010, GTIN 20763000091112, Lot Numbers: 2023041337, 202306C023; m) Model Number 77110, GTIN 00673978185989, Lot Numbers: 2023041342; GTIN 20763000091174, Lot Numbers: 2023041342, 202308C104; n) Model Number 77112, GTIN 00673978186009, Lot Numbers: 2023041343; GTIN 20763000091181, Lot Numbers: 2023041343, 202308C106; o) Model Number 77420, GTIN 20763000135625, Lot Numbers: 2023040668, 2023040671, 202306C032, 202307C005; p) Model Number 77422, GTIN 20763000135632, Lot Numbers: 2023040966, 2023041355, 202306C043, 202306C046; q) Model Number 77522, GTIN 20763000135557, Lot Numbers: 2023041361, 2023041364, 202306C051; r) Model Number 77622, GTIN 00763000135676, Lot Numbers: 2023040971; GTIN 20763000135670, Lot Numbers: 2023040971, 2023040974, 2023040978, 2023040980, 202306C061, 202307C029, 202307C030; s) Model Number 77524, GTIN 20763000135564, Lot Numbers: 2023041365, 202306C052; t) Model Number 72424, GTIN 20643169485468, Lot Numbers: 2023040940; u) Model Number 72120, GTIN 00643169485938, Lot Numbers: 2023041326; GTIN 20643169485932, lot Numbers: 2023041326, 202305C184; v) Model Number 72224, GTIN 20613994879701, Lot Numbers: 2023041332

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

11 devices cleared under K840002 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

How recalls are matched to devices · Editorial policy · Report an error on this page