Z-1017-2013Class II

Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter...

Name: Z-1017-2013 Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2013-03-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-03-13 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the... on 2013-03-13. FDA classified it as Class II and gives the reason as "Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1017-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Posted: 2013-03-28
Terminated: 2013-11-21
Recalling firm: Medtronic, Inc.
Product: Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
FDA root cause: Mixed-up of materials/components
Action: Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612.
Quantity in commerce: 225 units
Distribution: Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Product codes and lots: Lot number GFWA0387

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1017-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1017-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code DQX

K101339Class IIArcher Super Stiff GuidewiresMedtronic, Inc. / cleared 2010-08-31

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)