Z-0160-2011

Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is...

Name: Z-0160-2011 Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is...
Creator: Edwards Lifesciences, Llc
Published: 2010-06-25
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2010-06-25 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, Llc began a recall of Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient... on 2010-06-25. The reason FDA records is "The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0160-2011
Status: Terminated
Initiated: 2010-06-25
Posted: 2010-10-28
Terminated: 2011-05-24
Recalling firm: Edwards Lifesciences LLC
Product: Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
Product code: DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Reason for recall: The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
Product codes and lots: Lot Numbers: 58822824; 58821774

Product code DXG

K060660Class IIEw200 System (Oxygen Saturation Monitoring System) and Presep Oximetry CatheterEdwards Lifesciences, LLC / cleared 2006-04-25

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)