Z-0623-2010

Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire...

Name: Z-0623-2010 Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire...
Creator: Cordis Corporation
Published: 2009-08-25
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2009-08-25 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile... on 2009-08-25. The reason FDA records is "Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number)". 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-0623-2010
Status: Terminated
Initiated: 2009-08-25
Posted: 2010-01-13
Terminated: 2010-08-11
Recalling firm: Cordis US Corp.
Product: Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.
Quantity in commerce: 145 units
Distribution: Nationwide distribution.
Product codes and lots: Lots 80000521 and 80000584

Product code DQX

K011905Class IISniper Elite Model-or-E3872xx SeriesMaxxim Medical / cleared 2001-08-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)