Cook Incorporated Balloon Catheter Recall

Cook Incorporated Issues Recall of Balloon Catheters, Following Reports of Balloons Bursting Below the Rated Burst Pressure

UNITED STATES – As reported online by www.fda.gov, Cook Incorporated issued a recall of balloon catheters after receiving reports of some balloons bursting below the rated burst pressure.

Cook Incorporated, a medical device manufacturer, recently recalled versions of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4xm.  Because the failure of this device has the potential to cause patients to sustain injuries or death, the United States Food and Drug Administration (FDA) has reported the recall as Class I, which is the most serious type of recall classification available.

Cook Incorporated’s Advance Enforcer Balloon Catheter is used in percutaneous transluminal angioplasty (PTA) procedures to open a patient’s blocked and narrowed arteries that supply blood to the legs.  Cook Incorporated received complaints that some balloons were bursting below their rated/intended burst pressure.  While no injuries or deaths have been reported, there are a significant number of similar complaints that have prompted Cook Incorporated to address and cure the defect.

The FDA’s Class I recall safety notification provides the following information regarding the specific versions of the Advance Enforcer Balloon Catheter:

• Model Numbers

• • 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248;
  • 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252; and
  • 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257.
• Lot Numbers
  • 9234424;
  • 9331618;
  • 9212015;
  • 9243035;
  • 9320430;
  • 9386804;
  • 9338194;
  • 9234423;
  • 9278982;
  • 9209468;
  • 9248603; and
  • 9320429.
• Manufacturing Dates – October 3, 2018 to December 17, 2018
• Distribution Dates – October 29, 2018 to March 21, 2019
• Total Number of Devices Recalled in the United States – 33
• Date Recall Was Initiated by Cook Incorporated – May 24, 2019

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