510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1802-2024Class II

Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45...

Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Medtronic Perfusion Systems began a recall of Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000 on . FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1802-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic Perfusion Systems
Product
Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000
Product code
DXS Gauge, Pressure, Coronary, 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
1624 units
Distribution
Worldwide distribution.
Product codes and lots
a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1802-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1793-2024Class IIOngoingVoluntary: Firm initiated
Z-1794-2024Class IIOngoingVoluntary: Firm initiated
Z-1795-2024Class IIOngoingVoluntary: Firm initiated
Z-1796-2024Class IIOngoingVoluntary: Firm initiated
Z-1797-2024Class IIOngoingVoluntary: Firm initiated
Z-1798-2024Class IIOngoingVoluntary: Firm initiated
Z-1799-2024Class IIOngoingVoluntary: Firm initiated
Z-1800-2024Class IIOngoingVoluntary: Firm initiated
Z-1801-2024Class IIOngoingVoluntary: Firm initiated
Z-1802-2024Class IIOngoingVoluntary: Firm initiated
Z-1803-2024Class IIOngoingVoluntary: Firm initiated
Z-1804-2024Class IIOngoingVoluntary: Firm initiated
Z-1805-2024Class IIOngoingVoluntary: Firm initiated