Venture Catheter Recall [US]


US FlagUS/Silver Spring: Logo - Venture CathetersVascular Solutions, Inc. recalls all batch/lots worldwide of Venture Catheters due to suspected extraneous material in the inner lumen of the distal Catheter tip and consequential component detachment or extrusion during use, embolism, serious injury and/or death hazards. FDA: http://ht.ly/Dkzn30d8YmD

Direct link: https://www.fda.gov/Safety/Recalls/ucm564419.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Catheters are subject to this recall (in alphanumeric order):

  • Catheter product code: 5820; batch/lot: 582455
  • Catheter product code: 5820; batch/lot: 582588
  • Catheter product code: 5820; batch/lot: 583022
  • Catheter product code: 5820; batch/lot: 583409
  • Catheter product code: 5820; batch/lot: 584469
  • Catheter product code: 5820; batch/lot: 584470
  • Catheter product code: 5820; batch/lot: 585180
  • Catheter product code: 5820; batch/lot: 585458
  • Catheter product code: 5820; batch/lot: 585787
  • Catheter product code: 5820; batch/lot: 587035
  • Catheter product code: 5820; batch/lot: 587036
  • Catheter product code: 5820; batch/lot: 587775
  • Catheter product code: 5820; batch/lot: 588097
  • Catheter product code: 5820; batch/lot: 588098
  • Catheter product code: 5820; batch/lot: 588794
  • Catheter product code: 5820; batch/lot: 589885
  • Catheter product code: 5820; batch/lot: 589886
  • Catheter product code: 5820; batch/lot: 590172
  • Catheter product code: 5820; batch/lot: 590776
  • Catheter product code: 5820; batch/lot: 591196
  • Catheter product code: 5820; batch/lot: 591198
  • Catheter product code: 5820; batch/lot: 592080
  • Catheter product code: 5820; batch/lot: 592526
  • Catheter product code: 5820; batch/lot: 593080
  • Catheter product code: 5820; batch/lot: 593519
  • Catheter product code: 5820; batch/lot: 593720
  • Catheter product code: 5820; batch/lot: 594204
  • Catheter product code: 5820; batch/lot: 594421
  • Catheter product code: 5820; batch/lot: 595195
  • Catheter product code: 5820; batch/lot: 595418
  • Catheter product code: 5820; batch/lot: 597293
  • Catheter product code: 5820; batch/lot: 597771
  • Catheter product code: 5820; batch/lot: 597967
  • Catheter product code: 5820; batch/lot: 598903
  • Catheter product code: 5820; batch/lot: 599045
  • Catheter product code: 5820; batch/lot: 599466
  • Catheter product code: 5820; batch/lot: 599903
  • Catheter product code: 5820; batch/lot: 601745
  • Catheter product code: 5820; batch/lot: 603987
  • Catheter product code: 5820; batch/lot: 603988
  • Catheter product code: 5820; batch/lot: 603991
  • Catheter product code: 5820; batch/lot: 604500
  • Catheter product code: 5821; batch/lot: 581713
  • Catheter product code: 5821; batch/lot: 583410
  • Catheter product code: 5821; batch/lot: 584471
  • Catheter product code: 5821; batch/lot: 585459
  • Catheter product code: 5821; batch/lot: 586408
  • Catheter product code: 5821; batch/lot: 586972
  • Catheter product code: 5821; batch/lot: 587408
  • Catheter product code: 5821; batch/lot: 588099
  • Catheter product code: 5821; batch/lot: 589268
  • Catheter product code: 5821; batch/lot: 589754
  • Catheter product code: 5821; batch/lot: 590404
  • Catheter product code: 5821; batch/lot: 591197
  • Catheter product code: 5821; batch/lot: 592081
  • Catheter product code: 5821; batch/lot: 592924
  • Catheter product code: 5821; batch/lot: 593520
  • Catheter product code: 5821; batch/lot: 595196
  • Catheter product code: 5821; batch/lot: 595419
  • Catheter product code: 5821; batch/lot: 596020
  • Catheter product code: 5821; batch/lot: 597294
  • Catheter product code: 5821; batch/lot: 599650
  • Catheter product code: 5821; batch/lot: 601196
  • Catheter product code: 5821; batch/lot: 601746
  • Catheter product code: 5821; batch/lot: 602260
  • Catheter product code: 5821; batch/lot: 603990
  • Catheter product code: 5821; batch/lot: 604049
  • Catheter product code: 5821; batch/lot: 605617
  • Catheter product code: 5822; batch/lot: 588100
  • Catheter product code: 5822; batch/lot: 590562
  • Catheter product code: 5822; batch/lot: 597905
  • Catheter product code: 5822; batch/lot: 599777
  • Catheter product code: 5822; batch/lot: 604862

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, this worldwide recall affects 4,679 Catheter units distributed in the United States. All unexpired lots of the Rapid Exchange (“RX”), Over-the-Wire (“OTW”) and Coronary Sinus (“CS”) versions of the product have been recalled due to the potential for excess material to be present within the inner lumen of the distal Catheter tip.

According to Vascular Solutions, it possible that this excess material may separate from the Catheter during use and pose a potential risk of Embolism, which could result in serious injury. At press time, no serious injuries or death have been reported in association with this issue.

If you believe you have purchased or have in your possession any of the recalled Catheters, please do not use them in any medical procedure. Instead, return these medical devices to the distributor where you purchased them for a full refund or replacement.

Please note: the US Food and Drug Administration (“FDA”) has classified this matter as a Class I Recall. The FDA defines a Class I Recall as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

If you have any questions about this recall, please contact the company at 1-888-240-6001 from 8:00 AM to 5:00 PM Central Time or by e-mail at customerservice@vasc.com.

==> To see other recalls and notifications caused by suspected failure of a medical device such as a Catheter, please search for “device” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected failure of a Catheter, please search for “catheter” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 8880-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe Meat, Poultry or Processed Egg product you purchased in the US [external: new window opens]:
==> https://ccms.fsis.usda.gov/
==> You can also all the toll-free USDA Meat and Poultry Hotline at 1-888-674-6854
Search for a recalled product on the USDA Web archive [external: new window opens]:
==> https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive

We welcome your feedback:
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E. & O. E.

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