Z-2441-2012Class II

Sleek OTWREF 426-1201XInflated Balloon Dia/mm1.25Inflated Balloon Length/mm15Usable...

Name: Z-2441-2012 Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable...
Creator: Cordis Corporation
Published: 2011-01-31
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2011-01-31 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot... on 2011-01-31. FDA classified it as Class II and gives the reason as "On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2441-2012
Classification: Class II
Status: Terminated
Initiated: 2011-01-31
Posted: 2012-09-21
Terminated: 2013-11-26
Recalling firm: Cordis US Corp.
Product: Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Cordis (Johnson & Johnson Company) sent an Urgent Medical Device Field Corrective Action Notice dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review, sign, and return the enclosed Acknowledgment Form directly to Cordis at the fax number on the form, or to their local sales representative. Pass the revised labeling notice to all who need to be aware within their facility or organization. Also, customers were asked to maintain awareness of this notice until all affected product in their facility has been consumed. In addition to their local Cordis representative, they may contact the normal HCS Customer Service number at 1-800-327-7714, option 1, option 3. For questions regarding this recall call 786-313-2365.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution - USA and Germany
Product codes and lots: Lot #50027149

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2441-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2441-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21
Z-2442-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-21

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)