Z-1793-2024Class II

Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020...

Name: Z-1793-2024 Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020...
Creator: Medtronic Perfusion Systems
Published: 2024-03-19
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of 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... on 2024-03-19. FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1793-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-19
Posted: 2024-05-10
Recalling firm: Medtronic Perfusion Systems
Product: 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
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Potential for unsealed sterile packing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 13033 units
Distribution: Worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1793-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1793-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1794-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1795-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1796-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1797-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1798-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1799-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1800-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1801-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1802-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1803-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1804-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1805-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10

Product code DWF

K840002Class IIArterial Cannula Curved Beveled TipDlp, Inc. / cleared 1984-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)