{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Alameda",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86989",
      "recalling_firm": "Penumbra Inc.",
      "address_1": "1 Penumbra",
      "address_2": "N/A",
      "postal_code": "94502-7610",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S  (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.",
      "recall_number": "Z-0850-2021",
      "product_description": "Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT     The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature.  The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.",
      "product_quantity": "0 catheters",
      "reason_for_recall": "The catheter may become susceptible to distal tip damage during use.  Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.",
      "recall_initiation_date": "20201215",
      "center_classification_date": "20210118",
      "termination_date": "20240514",
      "report_date": "20210127",
      "code_info": "Product Name:  Penumbra JET 7 Reperfusion Catheter and  Penumbra Hi-Flow Aspiration Tubing  Catalog Number:  5MAXJET7L138KIT  UDI Code:  00815948021594    Lot Number Range:  F97123 thru F98981  Note - none were distributed",
      "more_code_info": ""
    }
  ]
}