Facility

Cordis US Corp.

30 recall(s) on record — most severe on record: Class I.

Key facts

30recalls · worst Class I

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1016427
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	14201 N.W. 60TH AVE. Miami Lakes, FL, US 33014
Registration status	Active · expires 2026
Parent company	Cordis US Corp. (owner-operator 1016427)
Brand names	Powerflex Pro Percutaneous Transluminal Angioplasty Catheter

Activity by year

Recalls (30)
Inspections (4)

Devices registered here (1)

Catheter, Angioplasty, Peripheral, Transluminal
Product code LIT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

20252 records

Class IIOngoing2025-03-04
product mix-up; Vascular stent labeled as one size but contains a different size.
Class IIOngoing2025-02-07
Catheter manufactured at the incorrect length.

20233 records

Class IIOngoing2023-11-28
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, My…
Class IOngoing2023-09-26
Non-sterile product labeled as sterile was distributed.
Class IOngoing2023-03-24
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.

20222 records

Class IIOngoing2022-11-07
There is a potential for separation at the male connector.
Class IIOngoing2022-05-20
Potential for stent dislodgement and associated failures related to two specific sizes of the device.

20215 records

Class IIOngoing2021-10-01
There is a potential for distal tip dislodgement or separation.
Class ITerminated2021-07-21
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
Class IITerminated2021-07-19
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Class IITerminated2021-06-09
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Class ICompleted2021-02-11
Distal tip may become separated from the lumen wire in specific lots.

20201 record

Class IITerminated2020-01-08
Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

20192 records

Class IITerminated2019-10-04
Product was manufactured utilizing an expired inner body.
Class IIITerminated2019-02-07
Frayed pieces of the mounting card being inside the primary packaging.

20181 record

Class IITerminated2018-09-05
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).

20172 records

Class IITerminated2017-11-15
Potential for cracked luer hubs
Class IITerminated2017-02-16
Deployment Difficulty.

20161 record

Class IITerminated2016-05-04
Inability to deploy the stent or partial stent deployment.

20151 record

Class IITerminated2015-12-31
Incorrect cannula of the sheath introducer (smaller than intended).

20143 records

Class IITerminated2014-12-22
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Class IITerminated2014-06-23
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflati…
Class IITerminated2014-04-15
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.

20135 records

Class IITerminated2013-09-27
Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous pro…
Class IITerminated2013-08-12
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Class IITerminated2013-04-23
Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Class ITerminated2013-03-29
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Class IITerminated2013-02-05
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

20121 record

Class IITerminated2012-10-29
Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.

20111 record

Class IITerminated2011-01-31
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.

FDA inspections (4)

VAI2022-06-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2018-01-12
Voluntary Action Indicated · Bioresearch Monitoring · citations posted
NAI2016-07-06
No Action Indicated · Compliance: Devices; Project Evaluation: Devices
NAI2016-03-31
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Cordis US Corp. (FEI 1016427) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1016427-cordis-us-corp/

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