Z-1687-2019 Class II Terminated
FDA device recall Z-1687-2019 was initiated by Abbott Vascular on May 1, 2019 and is designated Class II. Reason for recall: Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force… The recall status is terminated (terminated December 11, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- May 1, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Reason for Recall
Distribution Pattern
U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MACAU, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED KINGDOM